Patient & Survivor Care

LAS VEGAS – When it comes to discussing the cardiotoxicity of cancer pharmacotherapies, it often seems that oncologists and cardiologists are on different planets.

“You will see wildly different toxicity numbers. … One trial will report 3% cardiotoxicity; another studying the same regimen will report 30%. It’s usually because they’re using vastly different definitions of toxicity,” Dr. Ronald M. Witteles said at the annual meeting of the Heart Failure Society of America.

“The typical clinical trial definition of a cardiac event in a cancer treatment trial is new symptomatic NYHA class III or IV heart failure or cardiac death; that’s it,” added Dr. Witteles, a cardiologist at Stanford (Calif.) University.

The consensus within the emerging field of cardio-oncology is that that simply isn’t good enough. A reasonable definition of cancer treatment–related cardiotoxicity must be far broader, encompassing a drop in left ventricular ejection fraction (LVEF) of greater than 10% from normal-range pretreatment to below the threshold of normal, regardless of whether that decline is accompanied by symptoms, as well as the development of an acute coronary syndrome or symptomatic arrhythmia, according to Dr. Daniel J. Lenihan, president of the International Cardioncology Society, an organization devoted to closer collaboration between the two medical specialties.

“Development of cardiomyopathy during cancer therapy is a lot more common than most people think,” emphasized Dr. Lenihan, professor of medicine and director of clinical research in the division of cardiovascular medicine at Vanderbilt University, Nashville, Tenn.

Dr. Witteles noted that the product labeling for doxorubicin quotes a preposterously low 1%-2% probability of developing impaired myocardial function at a total cumulative dose of 300 mg/m², which is what’s typically used in treating lymphoma. That’s because the primary source of that estimate is 35-year-old data in which there was no routine measurement of LVEF and the diagnosis of impaired myocardial function was made by the treating oncologist on the basis of clinical signs and symptoms.

There are far better data available, but they’re not in the product label. Dr. Witteles cited as an example a more recent study featuring routine LVEF monitoring, where the incidence of a greater than 10% fall from normal to below normal at a cumulative dose of 300 mg/m² wasn’t 1%-2%; it was 16% (Cancer 2003;97:2869-79).

He added that current evidence indicates that a fall in LVEF of more than 10%, taking a patient from normal range to below normal, occurs in 7%-8% of patients on an anthracycline such as doxorubicin at a cumulative dose of 240 mg/m^2, as is typical in treating breast cancer. The incidence with trastuzumab (Herceptin) when prescribed after completion of anthracycline-based chemotherapy is about 25%; however, when trastuzumab is given in an anthracycline-free regimen, the rate drops to 9%-10%. A study by Dr. Witteles and his coworkers pegged the rate in cancer patients treated with sunitinib (Sutent) or other tyrosine kinase inhibitors at about 15% (JACC Heart Fail. 2013;1:72-8).

“Any way you slice it, that’s a whole lot of people,” he commented.

Dr. Lenihan reported receiving research support from Singulex, Millenium, and Acorda as well as serving as a consultant to Onyx and Roche. Dr. Witteles declared having no financial conflicts.

[email protected]

LAS VEGAS – When it comes to discussing the cardiotoxicity of cancer pharmacotherapies, it often seems that oncologists and cardiologists are on different planets.

“You will see wildly different toxicity numbers. … One trial will report 3% cardiotoxicity; another studying the same regimen will report 30%. It’s usually because they’re using vastly different definitions of toxicity,” Dr. Ronald M. Witteles said at the annual meeting of the Heart Failure Society of America.

“The typical clinical trial definition of a cardiac event in a cancer treatment trial is new symptomatic NYHA class III or IV heart failure or cardiac death; that’s it,” added Dr. Witteles, a cardiologist at Stanford (Calif.) University.

The consensus within the emerging field of cardio-oncology is that that simply isn’t good enough. A reasonable definition of cancer treatment–related cardiotoxicity must be far broader, encompassing a drop in left ventricular ejection fraction (LVEF) of greater than 10% from normal-range pretreatment to below the threshold of normal, regardless of whether that decline is accompanied by symptoms, as well as the development of an acute coronary syndrome or symptomatic arrhythmia, according to Dr. Daniel J. Lenihan, president of the International Cardioncology Society, an organization devoted to closer collaboration between the two medical specialties.

“Development of cardiomyopathy during cancer therapy is a lot more common than most people think,” emphasized Dr. Lenihan, professor of medicine and director of clinical research in the division of cardiovascular medicine at Vanderbilt University, Nashville, Tenn.

Dr. Witteles noted that the product labeling for doxorubicin quotes a preposterously low 1%-2% probability of developing impaired myocardial function at a total cumulative dose of 300 mg/m², which is what’s typically used in treating lymphoma. That’s because the primary source of that estimate is 35-year-old data in which there was no routine measurement of LVEF and the diagnosis of impaired myocardial function was made by the treating oncologist on the basis of clinical signs and symptoms.

There are far better data available, but they’re not in the product label. Dr. Witteles cited as an example a more recent study featuring routine LVEF monitoring, where the incidence of a greater than 10% fall from normal to below normal at a cumulative dose of 300 mg/m² wasn’t 1%-2%; it was 16% (Cancer 2003;97:2869-79).

He added that current evidence indicates that a fall in LVEF of more than 10%, taking a patient from normal range to below normal, occurs in 7%-8% of patients on an anthracycline such as doxorubicin at a cumulative dose of 240 mg/m^2, as is typical in treating breast cancer. The incidence with trastuzumab (Herceptin) when prescribed after completion of anthracycline-based chemotherapy is about 25%; however, when trastuzumab is given in an anthracycline-free regimen, the rate drops to 9%-10%. A study by Dr. Witteles and his coworkers pegged the rate in cancer patients treated with sunitinib (Sutent) or other tyrosine kinase inhibitors at about 15% (JACC Heart Fail. 2013;1:72-8).

“Any way you slice it, that’s a whole lot of people,” he commented.

Dr. Lenihan reported receiving research support from Singulex, Millenium, and Acorda as well as serving as a consultant to Onyx and Roche. Dr. Witteles declared having no financial conflicts.

[email protected]

LAS VEGAS – When it comes to discussing the cardiotoxicity of cancer pharmacotherapies, it often seems that oncologists and cardiologists are on different planets.

“You will see wildly different toxicity numbers. … One trial will report 3% cardiotoxicity; another studying the same regimen will report 30%. It’s usually because they’re using vastly different definitions of toxicity,” Dr. Ronald M. Witteles said at the annual meeting of the Heart Failure Society of America.

“The typical clinical trial definition of a cardiac event in a cancer treatment trial is new symptomatic NYHA class III or IV heart failure or cardiac death; that’s it,” added Dr. Witteles, a cardiologist at Stanford (Calif.) University.

The consensus within the emerging field of cardio-oncology is that that simply isn’t good enough. A reasonable definition of cancer treatment–related cardiotoxicity must be far broader, encompassing a drop in left ventricular ejection fraction (LVEF) of greater than 10% from normal-range pretreatment to below the threshold of normal, regardless of whether that decline is accompanied by symptoms, as well as the development of an acute coronary syndrome or symptomatic arrhythmia, according to Dr. Daniel J. Lenihan, president of the International Cardioncology Society, an organization devoted to closer collaboration between the two medical specialties.

“Development of cardiomyopathy during cancer therapy is a lot more common than most people think,” emphasized Dr. Lenihan, professor of medicine and director of clinical research in the division of cardiovascular medicine at Vanderbilt University, Nashville, Tenn.

Dr. Witteles noted that the product labeling for doxorubicin quotes a preposterously low 1%-2% probability of developing impaired myocardial function at a total cumulative dose of 300 mg/m², which is what’s typically used in treating lymphoma. That’s because the primary source of that estimate is 35-year-old data in which there was no routine measurement of LVEF and the diagnosis of impaired myocardial function was made by the treating oncologist on the basis of clinical signs and symptoms.

There are far better data available, but they’re not in the product label. Dr. Witteles cited as an example a more recent study featuring routine LVEF monitoring, where the incidence of a greater than 10% fall from normal to below normal at a cumulative dose of 300 mg/m² wasn’t 1%-2%; it was 16% (Cancer 2003;97:2869-79).

He added that current evidence indicates that a fall in LVEF of more than 10%, taking a patient from normal range to below normal, occurs in 7%-8% of patients on an anthracycline such as doxorubicin at a cumulative dose of 240 mg/m^2, as is typical in treating breast cancer. The incidence with trastuzumab (Herceptin) when prescribed after completion of anthracycline-based chemotherapy is about 25%; however, when trastuzumab is given in an anthracycline-free regimen, the rate drops to 9%-10%. A study by Dr. Witteles and his coworkers pegged the rate in cancer patients treated with sunitinib (Sutent) or other tyrosine kinase inhibitors at about 15% (JACC Heart Fail. 2013;1:72-8).

“Any way you slice it, that’s a whole lot of people,” he commented.

Dr. Lenihan reported receiving research support from Singulex, Millenium, and Acorda as well as serving as a consultant to Onyx and Roche. Dr. Witteles declared having no financial conflicts.

[email protected]

BOSTON – Medical residents in the United States appear to understand that cardiopulmonary resuscitation or intubation is highly unlikely to benefit patients with advanced cancers at the end of life, but the majority of residents surveyed said that they do not discuss code-status options or potentially beneficial palliative care with their dying patients.

“This was primarily due to residents’ perceptions of patient autonomy: Residents wanted patients to make their own decisions, without any influence from the doctor, which misses the concept of informed decision making. These incomplete discussions can cause at minimum improper documentation of patients’ wishes, and at most psychological harm, damage to the physician-patient relationship, and the potential for unwanted attempts at resuscitation,” said Dr. David J. Einstein, a resident at Beth Israel Deaconess Medical Center and Tufts Medical Center, both in Boston.

Despite their reluctance to have the discussion, however, the majority of residents said they preferred to discuss code status with patients themselves rather than hand it off to the attending physician, primarily out of a sense that it is their responsibility as physicians. Yet these physicians in training did not seem to feel that they were also responsible for providing guidance to patients, Dr. Einstein said at the Palliative Care in Oncology Symposium.

“We felt that this represented an unmet need in training and practice. Residents and attendings should be providing guidance on all medical interventions, including CPR, and if they aren’t sure what to recommend, then they themselves should be seeking guidance from other experts, before asking a patient to falsely choose between an intervention and death,” he said.

The first discussion of code status – do not resuscitate (DNR) or do not intubate (DNI) – may occur in the hospital, and is often left to a resident physician. Ideally, the physician and patient should discuss the patient’s prognosis, goals for care, evaluation of CPR as a means of meeting those goals, and a recommendation. But many residents lack training in the end-of-life discussion, which can have a significant impact on the quality of the patients’ remaining weeks or months of life.

Nationwide survey

Dr. Einstein and his colleagues conducted a nationwide survey to measure the likelihood that residents would discuss prognostic information and offer recommendations to patients with limited life expectancy. They also sought to determine why residents might be reluctant to provide discussion, and to evaluate their satisfaction with code-status discussions that both they and their attending physicians have conducted.

The survey presented respondents with a hypothetical case of a patient with stage IV adenocarcinoma of the lung metastatic to the brain. The patient, who has disease progression despite receiving first- and second-line therapy, presents to the emergency department with dyspnea and is slightly hypoxemic, but is not in distress. The patient has not previously established a code-status preference.

The investigators contacted 387 residency program directors by mail, 19 of whom agreed to participate and responded. They sent surveys to a total of 1,627 residents, 358 of which were completed and included.

The investigators found that slightly less than half of the respondents said they would share information with the patient about his/her prognosis and the relative benefit of CPR, and more than two-thirds said they would be unlikely to offer a specific recommendation.

“So even in the situation with a clearly declining patient, residents were as likely as not to provide the information needed to make an informed decision, and were far less likely to provide guidance on this decision,” Dr. Einstein said.

Asked the reason for their decisions, 69% of the residents who would not offer a recommendation said that the patient should make his/her own decision without any influence, and 26.5% said that the attending would not want them to offer a recommendation. Nonetheless, only 1.3% of this group said they believed that CPR would offer the patient a reasonable chance of resuscitation.

The majority of respondents who would offer a recommendation (93.5%) said they would recommend DNR and DNI.

Code-status talk a ‘responsibility’

When they were asked whether they would prefer the attending to discuss code status, nearly 70% of respondents disagreed.

Of those residents who said they preferred to retain the code-status discussion, 93.4% said they thought it was part of their responsibility as a physician, and 65.8% said they thought they had sufficient training and knowledge to do it. A minority in this group (2.5%) said that they would be likely to disagree with the attending’s estimate of prognosis, and 4.9% said they thought the attending would not share his/her estimate honestly.

When the authors asked about the residents’ general satisfaction with discussion of code status, “we learned two things: one, the residents are significantly more satisfied with their own discussions than their attendings’ discussions; and two, there is a substantial minority that is dissatisfied with all discussions, and a small number who are actually very satisfied,” Dr. Einstein said.

In a linear regression analysis testing for hypothesized correlations, the investigators found that more-senior residents were more likely to share prognostic information and make recommendations (P = .002). Residents who expressed an interest in hematology/oncology or palliative care specialization were also more likely to offer prognostic information, but not to make a recommendation about code status.

More-senior year of training correlated negatively with satisfaction with both the resident’s own and the attending’s discussion of code status.

“We found substantial dissatisfaction with code-status discussions in general, and we hypothesize that this is due to an internal conflict. When a resident knows that an intervention may be more harmful than beneficial, but thinks that the patient should make their own decision alone, then one may experience substantial frustration, and this would increase as training goes on and one becomes more sure of the outcomes of interventions like CPR,” Dr. Einstein said.

Generation gap

Evoking a potential generation gap between old-school doctors and the up-and-coming young physicians who by statute work fewer hours than their mentors had to, “I’m struck that [residents] don’t trust the attendings. When I was a resident, you didn’t do anything without asking the attending,” said Dr. Michael H. Levy, an invited discussant who is vice chair of medical oncology and director of the pain and palliative care program at Fox Chase Cancer Center, Philadelphia.

“I’m glad that the residents want to do it, but they have the same arrogance/ignorance that they don’t know how, so if we want them to do it, we have to train them,” he said.

The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC. The study was supported in part by the Conquer Cancer Foundation. Dr. Einstein and Dr. Levy reported having no relevant disclosures.

BOSTON – Medical residents in the United States appear to understand that cardiopulmonary resuscitation or intubation is highly unlikely to benefit patients with advanced cancers at the end of life, but the majority of residents surveyed said that they do not discuss code-status options or potentially beneficial palliative care with their dying patients.

“This was primarily due to residents’ perceptions of patient autonomy: Residents wanted patients to make their own decisions, without any influence from the doctor, which misses the concept of informed decision making. These incomplete discussions can cause at minimum improper documentation of patients’ wishes, and at most psychological harm, damage to the physician-patient relationship, and the potential for unwanted attempts at resuscitation,” said Dr. David J. Einstein, a resident at Beth Israel Deaconess Medical Center and Tufts Medical Center, both in Boston.

Despite their reluctance to have the discussion, however, the majority of residents said they preferred to discuss code status with patients themselves rather than hand it off to the attending physician, primarily out of a sense that it is their responsibility as physicians. Yet these physicians in training did not seem to feel that they were also responsible for providing guidance to patients, Dr. Einstein said at the Palliative Care in Oncology Symposium.

“We felt that this represented an unmet need in training and practice. Residents and attendings should be providing guidance on all medical interventions, including CPR, and if they aren’t sure what to recommend, then they themselves should be seeking guidance from other experts, before asking a patient to falsely choose between an intervention and death,” he said.

The first discussion of code status – do not resuscitate (DNR) or do not intubate (DNI) – may occur in the hospital, and is often left to a resident physician. Ideally, the physician and patient should discuss the patient’s prognosis, goals for care, evaluation of CPR as a means of meeting those goals, and a recommendation. But many residents lack training in the end-of-life discussion, which can have a significant impact on the quality of the patients’ remaining weeks or months of life.

Nationwide survey

Dr. Einstein and his colleagues conducted a nationwide survey to measure the likelihood that residents would discuss prognostic information and offer recommendations to patients with limited life expectancy. They also sought to determine why residents might be reluctant to provide discussion, and to evaluate their satisfaction with code-status discussions that both they and their attending physicians have conducted.

The survey presented respondents with a hypothetical case of a patient with stage IV adenocarcinoma of the lung metastatic to the brain. The patient, who has disease progression despite receiving first- and second-line therapy, presents to the emergency department with dyspnea and is slightly hypoxemic, but is not in distress. The patient has not previously established a code-status preference.

The investigators contacted 387 residency program directors by mail, 19 of whom agreed to participate and responded. They sent surveys to a total of 1,627 residents, 358 of which were completed and included.

The investigators found that slightly less than half of the respondents said they would share information with the patient about his/her prognosis and the relative benefit of CPR, and more than two-thirds said they would be unlikely to offer a specific recommendation.

“So even in the situation with a clearly declining patient, residents were as likely as not to provide the information needed to make an informed decision, and were far less likely to provide guidance on this decision,” Dr. Einstein said.

Asked the reason for their decisions, 69% of the residents who would not offer a recommendation said that the patient should make his/her own decision without any influence, and 26.5% said that the attending would not want them to offer a recommendation. Nonetheless, only 1.3% of this group said they believed that CPR would offer the patient a reasonable chance of resuscitation.

The majority of respondents who would offer a recommendation (93.5%) said they would recommend DNR and DNI.

Code-status talk a ‘responsibility’

When they were asked whether they would prefer the attending to discuss code status, nearly 70% of respondents disagreed.

Of those residents who said they preferred to retain the code-status discussion, 93.4% said they thought it was part of their responsibility as a physician, and 65.8% said they thought they had sufficient training and knowledge to do it. A minority in this group (2.5%) said that they would be likely to disagree with the attending’s estimate of prognosis, and 4.9% said they thought the attending would not share his/her estimate honestly.

When the authors asked about the residents’ general satisfaction with discussion of code status, “we learned two things: one, the residents are significantly more satisfied with their own discussions than their attendings’ discussions; and two, there is a substantial minority that is dissatisfied with all discussions, and a small number who are actually very satisfied,” Dr. Einstein said.

In a linear regression analysis testing for hypothesized correlations, the investigators found that more-senior residents were more likely to share prognostic information and make recommendations (P = .002). Residents who expressed an interest in hematology/oncology or palliative care specialization were also more likely to offer prognostic information, but not to make a recommendation about code status.

More-senior year of training correlated negatively with satisfaction with both the resident’s own and the attending’s discussion of code status.

“We found substantial dissatisfaction with code-status discussions in general, and we hypothesize that this is due to an internal conflict. When a resident knows that an intervention may be more harmful than beneficial, but thinks that the patient should make their own decision alone, then one may experience substantial frustration, and this would increase as training goes on and one becomes more sure of the outcomes of interventions like CPR,” Dr. Einstein said.

Generation gap

Evoking a potential generation gap between old-school doctors and the up-and-coming young physicians who by statute work fewer hours than their mentors had to, “I’m struck that [residents] don’t trust the attendings. When I was a resident, you didn’t do anything without asking the attending,” said Dr. Michael H. Levy, an invited discussant who is vice chair of medical oncology and director of the pain and palliative care program at Fox Chase Cancer Center, Philadelphia.

“I’m glad that the residents want to do it, but they have the same arrogance/ignorance that they don’t know how, so if we want them to do it, we have to train them,” he said.

The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC. The study was supported in part by the Conquer Cancer Foundation. Dr. Einstein and Dr. Levy reported having no relevant disclosures.

BOSTON – Medical residents in the United States appear to understand that cardiopulmonary resuscitation or intubation is highly unlikely to benefit patients with advanced cancers at the end of life, but the majority of residents surveyed said that they do not discuss code-status options or potentially beneficial palliative care with their dying patients.

“This was primarily due to residents’ perceptions of patient autonomy: Residents wanted patients to make their own decisions, without any influence from the doctor, which misses the concept of informed decision making. These incomplete discussions can cause at minimum improper documentation of patients’ wishes, and at most psychological harm, damage to the physician-patient relationship, and the potential for unwanted attempts at resuscitation,” said Dr. David J. Einstein, a resident at Beth Israel Deaconess Medical Center and Tufts Medical Center, both in Boston.

Despite their reluctance to have the discussion, however, the majority of residents said they preferred to discuss code status with patients themselves rather than hand it off to the attending physician, primarily out of a sense that it is their responsibility as physicians. Yet these physicians in training did not seem to feel that they were also responsible for providing guidance to patients, Dr. Einstein said at the Palliative Care in Oncology Symposium.

“We felt that this represented an unmet need in training and practice. Residents and attendings should be providing guidance on all medical interventions, including CPR, and if they aren’t sure what to recommend, then they themselves should be seeking guidance from other experts, before asking a patient to falsely choose between an intervention and death,” he said.

The first discussion of code status – do not resuscitate (DNR) or do not intubate (DNI) – may occur in the hospital, and is often left to a resident physician. Ideally, the physician and patient should discuss the patient’s prognosis, goals for care, evaluation of CPR as a means of meeting those goals, and a recommendation. But many residents lack training in the end-of-life discussion, which can have a significant impact on the quality of the patients’ remaining weeks or months of life.

Nationwide survey

Dr. Einstein and his colleagues conducted a nationwide survey to measure the likelihood that residents would discuss prognostic information and offer recommendations to patients with limited life expectancy. They also sought to determine why residents might be reluctant to provide discussion, and to evaluate their satisfaction with code-status discussions that both they and their attending physicians have conducted.

The survey presented respondents with a hypothetical case of a patient with stage IV adenocarcinoma of the lung metastatic to the brain. The patient, who has disease progression despite receiving first- and second-line therapy, presents to the emergency department with dyspnea and is slightly hypoxemic, but is not in distress. The patient has not previously established a code-status preference.

The investigators contacted 387 residency program directors by mail, 19 of whom agreed to participate and responded. They sent surveys to a total of 1,627 residents, 358 of which were completed and included.

The investigators found that slightly less than half of the respondents said they would share information with the patient about his/her prognosis and the relative benefit of CPR, and more than two-thirds said they would be unlikely to offer a specific recommendation.

“So even in the situation with a clearly declining patient, residents were as likely as not to provide the information needed to make an informed decision, and were far less likely to provide guidance on this decision,” Dr. Einstein said.

Asked the reason for their decisions, 69% of the residents who would not offer a recommendation said that the patient should make his/her own decision without any influence, and 26.5% said that the attending would not want them to offer a recommendation. Nonetheless, only 1.3% of this group said they believed that CPR would offer the patient a reasonable chance of resuscitation.

The majority of respondents who would offer a recommendation (93.5%) said they would recommend DNR and DNI.

Code-status talk a ‘responsibility’

When they were asked whether they would prefer the attending to discuss code status, nearly 70% of respondents disagreed.

Of those residents who said they preferred to retain the code-status discussion, 93.4% said they thought it was part of their responsibility as a physician, and 65.8% said they thought they had sufficient training and knowledge to do it. A minority in this group (2.5%) said that they would be likely to disagree with the attending’s estimate of prognosis, and 4.9% said they thought the attending would not share his/her estimate honestly.

When the authors asked about the residents’ general satisfaction with discussion of code status, “we learned two things: one, the residents are significantly more satisfied with their own discussions than their attendings’ discussions; and two, there is a substantial minority that is dissatisfied with all discussions, and a small number who are actually very satisfied,” Dr. Einstein said.

In a linear regression analysis testing for hypothesized correlations, the investigators found that more-senior residents were more likely to share prognostic information and make recommendations (P = .002). Residents who expressed an interest in hematology/oncology or palliative care specialization were also more likely to offer prognostic information, but not to make a recommendation about code status.

More-senior year of training correlated negatively with satisfaction with both the resident’s own and the attending’s discussion of code status.

“We found substantial dissatisfaction with code-status discussions in general, and we hypothesize that this is due to an internal conflict. When a resident knows that an intervention may be more harmful than beneficial, but thinks that the patient should make their own decision alone, then one may experience substantial frustration, and this would increase as training goes on and one becomes more sure of the outcomes of interventions like CPR,” Dr. Einstein said.

Generation gap

Evoking a potential generation gap between old-school doctors and the up-and-coming young physicians who by statute work fewer hours than their mentors had to, “I’m struck that [residents] don’t trust the attendings. When I was a resident, you didn’t do anything without asking the attending,” said Dr. Michael H. Levy, an invited discussant who is vice chair of medical oncology and director of the pain and palliative care program at Fox Chase Cancer Center, Philadelphia.

“I’m glad that the residents want to do it, but they have the same arrogance/ignorance that they don’t know how, so if we want them to do it, we have to train them,” he said.

The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC. The study was supported in part by the Conquer Cancer Foundation. Dr. Einstein and Dr. Levy reported having no relevant disclosures.

BOSTON – When a palliative care oncologist partners with a medical oncologist on everyday rounds and in everyday practice on an inpatient floor, both patients and the clinicians who provide their care benefit from the arrangement, an oncologist reports.

At Duke University Medical Center in Durham, N.C., where palliative care is integrated with medical oncology on an inpatient oncology ward, the “co-rounding” model is associated with improvements in quality outcomes, improved nursing and physician satisfaction, and increased collaboration and communication, said Dr. Richard F. Riedel of the medical center.

In a study comparing the periods before and after implementation of the co-rounding model, lengths of stay and 7- and 30-day readmission rates were significantly shorter with co-rounding.

“I’d like to think that decreased resource utilization through decreased ICU transfer rates and decreased readmissions will result in a cost savings that would certainly justify putting a second provider up on an inpatient ward,” he said at the Palliative Care in Oncology Symposium.

The co-rounding model was introduced at Duke in 2011. Under this system, a medical oncologist and palliative care oncologist meet three times daily with house staff, fellows, and other team members to discuss the care of all patients on the unit. They decide which physician will oversee care of which patient. Patients who have high symptom burdens, for example, might be assigned to the palliative care physician. The physicians and staff go on rounds together with support staff, including internal medicine house staff, physician assistants, and pharmacists, allowing both formal and “curbside” consultations about how best to manage each patient.

“Critical to the success of this model is open communication and collaboration. We have three points where we meet throughout the day, and we emphasize to our colleagues that we are one team – we do not work in silos,” Dr. Riedel said.

Before and after

To see whether the co-rounding model was really, as they thought, a better way of doing business, Dr. Riedel and his colleagues conducted a retrospective cohort analysis of all patients admitted to the solid tumor inpatient service before the intervention – 731 patients admitted from September 2008 through June 2010 – compared with 783 admitted from September 2011 through June 2012, in the first year of co-rounding.

They found that co-rounding was associated with a significantly lower mean length of stay (4.51 days pre-intervention to 4.16 post, P =.02), and in both 7-day and 30-day readmission rates (12.1% vs. 9.3%, P <.0001, and 32.1% vs 28.3%, P = .048, respectively).

Although there were numerically fewer ICU transfers post intervention, this difference was not significant. Similarly, there was a trend, albeit nonsignificant, toward more hospice referrals under co-rounding.

When the researchers surveyed registered nurses who worked in the unit during both periods, they found that most agreed that adding a palliative care specialist improved quality of care, allowed for earlier goals-of-care discussions with patients, improved the involvement of nurses in care planning, reduced stresses on the staff, and improved symptom management.

Importantly, the improvements came without making rounds take longer or detracting from any appropriate focus on oncologic care, the authors found.

Medical oncology faculty who had rounded at least 2 weeks under the new regimen were surveyed, and they uniformly reported that the palliative care providers added a valuable skill set, that palliative care was a necessary component of cancer care, and that the rounding experience was more enjoyable. They also agreed that palliative care is different from hospice care, and said they felt that the discussion of hospice for those patients with incurable disease did not come too soon in the course of care,

“Importantly, the majority of physicians felt that they learned some new ways to manage symptoms, and I can tell you that I certainly have. I’m a medical oncologist, I’m not a palliative-care trained physician,” Dr. Riedel said.

He acknowledged that the study was limited by its retrospective design and the lack of a patient satisfaction component. Also, the intervention occurred at a single large academic medical center, and involved a smaller physician-to-patient ratio that could have confounded results.

The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

BOSTON – When a palliative care oncologist partners with a medical oncologist on everyday rounds and in everyday practice on an inpatient floor, both patients and the clinicians who provide their care benefit from the arrangement, an oncologist reports.

At Duke University Medical Center in Durham, N.C., where palliative care is integrated with medical oncology on an inpatient oncology ward, the “co-rounding” model is associated with improvements in quality outcomes, improved nursing and physician satisfaction, and increased collaboration and communication, said Dr. Richard F. Riedel of the medical center.

In a study comparing the periods before and after implementation of the co-rounding model, lengths of stay and 7- and 30-day readmission rates were significantly shorter with co-rounding.

“I’d like to think that decreased resource utilization through decreased ICU transfer rates and decreased readmissions will result in a cost savings that would certainly justify putting a second provider up on an inpatient ward,” he said at the Palliative Care in Oncology Symposium.

The co-rounding model was introduced at Duke in 2011. Under this system, a medical oncologist and palliative care oncologist meet three times daily with house staff, fellows, and other team members to discuss the care of all patients on the unit. They decide which physician will oversee care of which patient. Patients who have high symptom burdens, for example, might be assigned to the palliative care physician. The physicians and staff go on rounds together with support staff, including internal medicine house staff, physician assistants, and pharmacists, allowing both formal and “curbside” consultations about how best to manage each patient.

“Critical to the success of this model is open communication and collaboration. We have three points where we meet throughout the day, and we emphasize to our colleagues that we are one team – we do not work in silos,” Dr. Riedel said.

Before and after

To see whether the co-rounding model was really, as they thought, a better way of doing business, Dr. Riedel and his colleagues conducted a retrospective cohort analysis of all patients admitted to the solid tumor inpatient service before the intervention – 731 patients admitted from September 2008 through June 2010 – compared with 783 admitted from September 2011 through June 2012, in the first year of co-rounding.

They found that co-rounding was associated with a significantly lower mean length of stay (4.51 days pre-intervention to 4.16 post, P =.02), and in both 7-day and 30-day readmission rates (12.1% vs. 9.3%, P <.0001, and 32.1% vs 28.3%, P = .048, respectively).

Although there were numerically fewer ICU transfers post intervention, this difference was not significant. Similarly, there was a trend, albeit nonsignificant, toward more hospice referrals under co-rounding.

When the researchers surveyed registered nurses who worked in the unit during both periods, they found that most agreed that adding a palliative care specialist improved quality of care, allowed for earlier goals-of-care discussions with patients, improved the involvement of nurses in care planning, reduced stresses on the staff, and improved symptom management.

Importantly, the improvements came without making rounds take longer or detracting from any appropriate focus on oncologic care, the authors found.

Medical oncology faculty who had rounded at least 2 weeks under the new regimen were surveyed, and they uniformly reported that the palliative care providers added a valuable skill set, that palliative care was a necessary component of cancer care, and that the rounding experience was more enjoyable. They also agreed that palliative care is different from hospice care, and said they felt that the discussion of hospice for those patients with incurable disease did not come too soon in the course of care,

“Importantly, the majority of physicians felt that they learned some new ways to manage symptoms, and I can tell you that I certainly have. I’m a medical oncologist, I’m not a palliative-care trained physician,” Dr. Riedel said.

He acknowledged that the study was limited by its retrospective design and the lack of a patient satisfaction component. Also, the intervention occurred at a single large academic medical center, and involved a smaller physician-to-patient ratio that could have confounded results.

The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

BOSTON – When a palliative care oncologist partners with a medical oncologist on everyday rounds and in everyday practice on an inpatient floor, both patients and the clinicians who provide their care benefit from the arrangement, an oncologist reports.

At Duke University Medical Center in Durham, N.C., where palliative care is integrated with medical oncology on an inpatient oncology ward, the “co-rounding” model is associated with improvements in quality outcomes, improved nursing and physician satisfaction, and increased collaboration and communication, said Dr. Richard F. Riedel of the medical center.

In a study comparing the periods before and after implementation of the co-rounding model, lengths of stay and 7- and 30-day readmission rates were significantly shorter with co-rounding.

“I’d like to think that decreased resource utilization through decreased ICU transfer rates and decreased readmissions will result in a cost savings that would certainly justify putting a second provider up on an inpatient ward,” he said at the Palliative Care in Oncology Symposium.

The co-rounding model was introduced at Duke in 2011. Under this system, a medical oncologist and palliative care oncologist meet three times daily with house staff, fellows, and other team members to discuss the care of all patients on the unit. They decide which physician will oversee care of which patient. Patients who have high symptom burdens, for example, might be assigned to the palliative care physician. The physicians and staff go on rounds together with support staff, including internal medicine house staff, physician assistants, and pharmacists, allowing both formal and “curbside” consultations about how best to manage each patient.

“Critical to the success of this model is open communication and collaboration. We have three points where we meet throughout the day, and we emphasize to our colleagues that we are one team – we do not work in silos,” Dr. Riedel said.

Before and after

To see whether the co-rounding model was really, as they thought, a better way of doing business, Dr. Riedel and his colleagues conducted a retrospective cohort analysis of all patients admitted to the solid tumor inpatient service before the intervention – 731 patients admitted from September 2008 through June 2010 – compared with 783 admitted from September 2011 through June 2012, in the first year of co-rounding.

They found that co-rounding was associated with a significantly lower mean length of stay (4.51 days pre-intervention to 4.16 post, P =.02), and in both 7-day and 30-day readmission rates (12.1% vs. 9.3%, P <.0001, and 32.1% vs 28.3%, P = .048, respectively).

Although there were numerically fewer ICU transfers post intervention, this difference was not significant. Similarly, there was a trend, albeit nonsignificant, toward more hospice referrals under co-rounding.

When the researchers surveyed registered nurses who worked in the unit during both periods, they found that most agreed that adding a palliative care specialist improved quality of care, allowed for earlier goals-of-care discussions with patients, improved the involvement of nurses in care planning, reduced stresses on the staff, and improved symptom management.

Importantly, the improvements came without making rounds take longer or detracting from any appropriate focus on oncologic care, the authors found.

Medical oncology faculty who had rounded at least 2 weeks under the new regimen were surveyed, and they uniformly reported that the palliative care providers added a valuable skill set, that palliative care was a necessary component of cancer care, and that the rounding experience was more enjoyable. They also agreed that palliative care is different from hospice care, and said they felt that the discussion of hospice for those patients with incurable disease did not come too soon in the course of care,

“Importantly, the majority of physicians felt that they learned some new ways to manage symptoms, and I can tell you that I certainly have. I’m a medical oncologist, I’m not a palliative-care trained physician,” Dr. Riedel said.

He acknowledged that the study was limited by its retrospective design and the lack of a patient satisfaction component. Also, the intervention occurred at a single large academic medical center, and involved a smaller physician-to-patient ratio that could have confounded results.

The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

BOSTON – For some, the words “palliative care” evoke thoughts of pain- and anxiety-relieving therapies at the end of life, when all other treatments have failed. But in fact, palliative care is, or should, be an integral part of cancer therapies from the outset, say experts in the care of cancer survivors.

“From the beginning, at the time of diagnosis and staging, we need to be thinking about palliative care,” said Dr. Patricia A. Ganz, director of Cancer Prevention and Control Research and the Patients and Survivors Program Area at the Jonsson Comprehensive Cancer Center, University of California, Los Angeles.

The ultimate aim of palliative care should be research and development of strategies to prevent the long-term and late effects of cancer treatment, she said at the Palliative Care in Oncology Symposium.

Long-term effects are symptoms or problems that begin during cancer treatment and persist when treatment ends, such as fatigue, cognitive complaints, or pain.

Late effects are those that may occur months or years after the end of therapy, such as second cancers, lymphedema, or congestive heart failure.

Dr. Ganz said that it is essential for oncologists to understand the biologic mechanisms of symptoms in order to provide validity and support for patient complaints, develop possible pharmacologic or behavioral solutions, and possibly prevent the development of symptoms in at risk patients. In addition, it is important to understand the potential relationships between symptoms, tumor biology, and disease progression.

Cancer-related fatigue

“Fatigue is an extremely common and distressing side effect of cancer and its treatment. We expect fatigue during treatment, anywhere from 60% to 90% of patients report moderate to severe symptoms of fatigue, and it can sometimes be a treatment-limiting side effect. But what many people are not prepared for, especially patients, is that it may continue after they have completed their primary treatment,” said Julienne E. Bower, Ph.D., of the departments of psychology and psychiatry/biobehavioral sciences at the University of California, Los Angeles.

“Perhaps because they feel like this is something that they are supposed to endure, because they have had this great and hopefully successful treatment for cancer, they often don’t talk about it with their clinicians and physicians, and fatigue is often undertreated. This may be in part because we don’t really understand the mechanisms underlying fatigue,” she said.

ASCO has developed and will soon publish evidence-based clinical practice guidelines for the screening, assessment, and management of cancer-related fatigue. The guidelines apply to patients who have completed therapy with curative intent, rather than patients currently in therapy.

Dr. Bower, who cochaired the guideline development committee, says the most important recommendation is that screening for fatigue should be a regular part of cancer follow-up. Patients with no or only mild fatigue, rated 0-3 on an analog scale, should continue to be monitored at subsequent follow-up visits. Patients with moderate to severe fatigue (4-10) should have a comprehensive fatigue assessment that includes a focused history of fatigue and evaluation of disease status, assessment for potential contributing factors such as medications or comorbidities such as depression, and, if warranted, laboratory evaluation.

The guidelines emphasize that all patients need counseling and education about fatigue, its persistence and prevalence, and general strategies for preventing or managing it, such as physical activity.

Patients with moderate to severe fatigue should be evaluated and treated for contributing factors. These patients may require more intensive treatments. Evidence from the literature supports recommendations for exercise, psychosocial therapies such as psychoeducation and cognitive behavioral therapy, and mind-body treatments such as yoga, acupuncture, and mindfulness, Dr. Bower said at the symposium cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

Inflammation fingered

“The problem here is that we don’t really know what causes fati­­gue, so we’re taking all these different approaches, nonspecific approaches, and I think we have been fortunate to have been having some positive effects. But obviously if we know what the mechanisms are and we know what the risk factors are, we’re going to be able to deliver much more targeted and effective interventions” she commented.

One area of particular interest is inflammation, which can be triggered when immune cells release proinflammatory cytokines (such as interleukins 1 and 6, and tumor necrosis factor–alpha) in response to cancer treatments, infection, and injury.

“These cytokines move their way up to the brain and they cause a variety of behavioral changes, including fatigue,” she said.

This hypothesis is supported by evidence that many patients who have posttreatment fatigue have elevated levels of inflammatory markers,” and we see this across the survivorship trajectory.”

Individual differences in inflammatory response and fatigue may be caused by differences in genetic variations in the expression of proinflammatory genes, setting the stage for inflammation and fatigue after cancer treatment, and suggesting the use of anti-inflammatory medication as potential treatments for fatigue, Dr. Bower explained.

BOSTON – For some, the words “palliative care” evoke thoughts of pain- and anxiety-relieving therapies at the end of life, when all other treatments have failed. But in fact, palliative care is, or should, be an integral part of cancer therapies from the outset, say experts in the care of cancer survivors.

“From the beginning, at the time of diagnosis and staging, we need to be thinking about palliative care,” said Dr. Patricia A. Ganz, director of Cancer Prevention and Control Research and the Patients and Survivors Program Area at the Jonsson Comprehensive Cancer Center, University of California, Los Angeles.

The ultimate aim of palliative care should be research and development of strategies to prevent the long-term and late effects of cancer treatment, she said at the Palliative Care in Oncology Symposium.

Long-term effects are symptoms or problems that begin during cancer treatment and persist when treatment ends, such as fatigue, cognitive complaints, or pain.

Late effects are those that may occur months or years after the end of therapy, such as second cancers, lymphedema, or congestive heart failure.

Dr. Ganz said that it is essential for oncologists to understand the biologic mechanisms of symptoms in order to provide validity and support for patient complaints, develop possible pharmacologic or behavioral solutions, and possibly prevent the development of symptoms in at risk patients. In addition, it is important to understand the potential relationships between symptoms, tumor biology, and disease progression.

Cancer-related fatigue

“Fatigue is an extremely common and distressing side effect of cancer and its treatment. We expect fatigue during treatment, anywhere from 60% to 90% of patients report moderate to severe symptoms of fatigue, and it can sometimes be a treatment-limiting side effect. But what many people are not prepared for, especially patients, is that it may continue after they have completed their primary treatment,” said Julienne E. Bower, Ph.D., of the departments of psychology and psychiatry/biobehavioral sciences at the University of California, Los Angeles.

“Perhaps because they feel like this is something that they are supposed to endure, because they have had this great and hopefully successful treatment for cancer, they often don’t talk about it with their clinicians and physicians, and fatigue is often undertreated. This may be in part because we don’t really understand the mechanisms underlying fatigue,” she said.

ASCO has developed and will soon publish evidence-based clinical practice guidelines for the screening, assessment, and management of cancer-related fatigue. The guidelines apply to patients who have completed therapy with curative intent, rather than patients currently in therapy.

Dr. Bower, who cochaired the guideline development committee, says the most important recommendation is that screening for fatigue should be a regular part of cancer follow-up. Patients with no or only mild fatigue, rated 0-3 on an analog scale, should continue to be monitored at subsequent follow-up visits. Patients with moderate to severe fatigue (4-10) should have a comprehensive fatigue assessment that includes a focused history of fatigue and evaluation of disease status, assessment for potential contributing factors such as medications or comorbidities such as depression, and, if warranted, laboratory evaluation.

The guidelines emphasize that all patients need counseling and education about fatigue, its persistence and prevalence, and general strategies for preventing or managing it, such as physical activity.

Patients with moderate to severe fatigue should be evaluated and treated for contributing factors. These patients may require more intensive treatments. Evidence from the literature supports recommendations for exercise, psychosocial therapies such as psychoeducation and cognitive behavioral therapy, and mind-body treatments such as yoga, acupuncture, and mindfulness, Dr. Bower said at the symposium cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

Inflammation fingered

“The problem here is that we don’t really know what causes fati­­gue, so we’re taking all these different approaches, nonspecific approaches, and I think we have been fortunate to have been having some positive effects. But obviously if we know what the mechanisms are and we know what the risk factors are, we’re going to be able to deliver much more targeted and effective interventions” she commented.

One area of particular interest is inflammation, which can be triggered when immune cells release proinflammatory cytokines (such as interleukins 1 and 6, and tumor necrosis factor–alpha) in response to cancer treatments, infection, and injury.

“These cytokines move their way up to the brain and they cause a variety of behavioral changes, including fatigue,” she said.

This hypothesis is supported by evidence that many patients who have posttreatment fatigue have elevated levels of inflammatory markers,” and we see this across the survivorship trajectory.”

Individual differences in inflammatory response and fatigue may be caused by differences in genetic variations in the expression of proinflammatory genes, setting the stage for inflammation and fatigue after cancer treatment, and suggesting the use of anti-inflammatory medication as potential treatments for fatigue, Dr. Bower explained.

BOSTON – For some, the words “palliative care” evoke thoughts of pain- and anxiety-relieving therapies at the end of life, when all other treatments have failed. But in fact, palliative care is, or should, be an integral part of cancer therapies from the outset, say experts in the care of cancer survivors.

“From the beginning, at the time of diagnosis and staging, we need to be thinking about palliative care,” said Dr. Patricia A. Ganz, director of Cancer Prevention and Control Research and the Patients and Survivors Program Area at the Jonsson Comprehensive Cancer Center, University of California, Los Angeles.

The ultimate aim of palliative care should be research and development of strategies to prevent the long-term and late effects of cancer treatment, she said at the Palliative Care in Oncology Symposium.

Long-term effects are symptoms or problems that begin during cancer treatment and persist when treatment ends, such as fatigue, cognitive complaints, or pain.

Late effects are those that may occur months or years after the end of therapy, such as second cancers, lymphedema, or congestive heart failure.

Dr. Ganz said that it is essential for oncologists to understand the biologic mechanisms of symptoms in order to provide validity and support for patient complaints, develop possible pharmacologic or behavioral solutions, and possibly prevent the development of symptoms in at risk patients. In addition, it is important to understand the potential relationships between symptoms, tumor biology, and disease progression.

Cancer-related fatigue

“Fatigue is an extremely common and distressing side effect of cancer and its treatment. We expect fatigue during treatment, anywhere from 60% to 90% of patients report moderate to severe symptoms of fatigue, and it can sometimes be a treatment-limiting side effect. But what many people are not prepared for, especially patients, is that it may continue after they have completed their primary treatment,” said Julienne E. Bower, Ph.D., of the departments of psychology and psychiatry/biobehavioral sciences at the University of California, Los Angeles.

“Perhaps because they feel like this is something that they are supposed to endure, because they have had this great and hopefully successful treatment for cancer, they often don’t talk about it with their clinicians and physicians, and fatigue is often undertreated. This may be in part because we don’t really understand the mechanisms underlying fatigue,” she said.

ASCO has developed and will soon publish evidence-based clinical practice guidelines for the screening, assessment, and management of cancer-related fatigue. The guidelines apply to patients who have completed therapy with curative intent, rather than patients currently in therapy.

Dr. Bower, who cochaired the guideline development committee, says the most important recommendation is that screening for fatigue should be a regular part of cancer follow-up. Patients with no or only mild fatigue, rated 0-3 on an analog scale, should continue to be monitored at subsequent follow-up visits. Patients with moderate to severe fatigue (4-10) should have a comprehensive fatigue assessment that includes a focused history of fatigue and evaluation of disease status, assessment for potential contributing factors such as medications or comorbidities such as depression, and, if warranted, laboratory evaluation.

The guidelines emphasize that all patients need counseling and education about fatigue, its persistence and prevalence, and general strategies for preventing or managing it, such as physical activity.

Patients with moderate to severe fatigue should be evaluated and treated for contributing factors. These patients may require more intensive treatments. Evidence from the literature supports recommendations for exercise, psychosocial therapies such as psychoeducation and cognitive behavioral therapy, and mind-body treatments such as yoga, acupuncture, and mindfulness, Dr. Bower said at the symposium cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

Inflammation fingered

“The problem here is that we don’t really know what causes fati­­gue, so we’re taking all these different approaches, nonspecific approaches, and I think we have been fortunate to have been having some positive effects. But obviously if we know what the mechanisms are and we know what the risk factors are, we’re going to be able to deliver much more targeted and effective interventions” she commented.

One area of particular interest is inflammation, which can be triggered when immune cells release proinflammatory cytokines (such as interleukins 1 and 6, and tumor necrosis factor–alpha) in response to cancer treatments, infection, and injury.

“These cytokines move their way up to the brain and they cause a variety of behavioral changes, including fatigue,” she said.

This hypothesis is supported by evidence that many patients who have posttreatment fatigue have elevated levels of inflammatory markers,” and we see this across the survivorship trajectory.”

Individual differences in inflammatory response and fatigue may be caused by differences in genetic variations in the expression of proinflammatory genes, setting the stage for inflammation and fatigue after cancer treatment, and suggesting the use of anti-inflammatory medication as potential treatments for fatigue, Dr. Bower explained.

BOSTON – An automated system for monitoring the symptoms of patients in home hospice and supporting their caregivers with coaching can both improve patient comfort and relieve at least some of the stress on the caregiver, said investigators in a pilot program.

In a prospective, randomized controlled trial, caregivers assigned to symptom care by phone, in which they received automated coaching tailored to the specific situation, had better overall vitality, and the patients they cared for had less fatigue and anxiety than caregiver-patient pairs assigned to usual care, reported Dr. Kathi Mooney, professor of nursing at the University of Utah College of Nursing, Salt Lake City.

“The family inclusion in hospice care, the philosophy around that, offers the opportunity to extend PROs [patient-reported outcomes] to FCROs, family caregiver reported outcomes. We call that an opportunity to use electronic monitoring to monitor a family,” she said at the Palliative Care in Oncology Symposium.

Dr. Mooney and her colleagues have previously reported on the use of automated symptom monitoring for support of patients undergoing ambulatory chemotherapy. In the current study, she described its application in home-based end-of-life care to support both the patient and the caregiver.

The investigators recruited 319 cancer patient/caregiver dyads from 12 hospices in Illinois, Massachusetts, Oregon, and Utah. The mean age of the patients was 72 years, and the mean age of caregivers was 59 years.

The caregivers were randomly assigned either to the symptom care by phone (SCP) system or to usual care. The SCP system is an automated system in which caregivers phone in to report the patient’s symptoms and their own levels of stress, anxiety, etc., and receive automated responses based on the severity of symptoms and number of days reported without relief. The system offers both patient care and self-care strategies, and identifies and reinforces issues that should be addressed by contacting the hospice team. At the end of the call, the data are sent to the nurse, including alerts to matters that require prompt attention.

Caregivers in each group made daily automated monitoring calls to report 1 or more of 11 patient symptoms and 5 caregiver symptoms on a 0-10 scale, and to report the patient’s and their own distress about the symptoms.

“We have developed algorithms to provide just-in-time, tailored suggestions related to the pattern that they have reported,” Dr. Mooney said.

Data reported by caregivers in the control (usual care) group were recorded but not acted upon, whereas data reported by those in the SCP intervention group triggered the automated coaching and hospice nurse alerts for moderate to severe symptoms.

“People in the usual care group understood that they were just contributing symptom information, and they were told on every call and at consent that if they had any concerns to call their hospice nurse,” Dr. Mooney said.

For clinicians, the automated system triggers an alert at preset thresholds of severity (4-10), as well as trend alerts. Hospice nurses have online and mobile access to the alert website, where they can view a report of symptoms over the previous 24 hours, and review graphs of symptoms over time to see trends. The nurses were instructed to log that they had seen the alert and what their planned action was, which was left to their professional judgment.

The average length of the calls was 7 minutes, 4 seconds for the usual care group, and 7 minutes, 59 seconds for the intervention group. Control group caregivers completed 59% of expected calls, and those in the intervention group completed 64%.

Reported symptoms present in more than 50% of patients included fatigue (88.8%), pain (60.2%), eating/drinking problems (76.6%), difficulty thinking (69.6%), anxiety (67.6%), negative mood (67.3%), bowel problems (61%), and trouble sleeping (58.3%).

Among caregivers, 73.3% reported fatigue, 66.7% anxiety, 61% trouble sleeping, and 57.1% negative mood.

In a mixed-effects model looking at caregiver vitality – a composite of caregiver symptoms – the authors found that the severity of symptoms in the usual care group increased steadily over the course of hospice care, out to at least 91 days. In contrast, the severity of symptoms among caregivers in the SCP group rose only slightly. The between-group difference was significant (P < .001).

Similarly, among patients the overall symptom severity scores were lower for those in the intervention group than for controls (P =.03). Additionally, the onset of benefit, defined as time to the first symptom-free day, was significantly earlier among patients in the SCP group (P < .02)

Patterns of patient and fatigue during the last 8 weeks of life also favored the symptom-care intervention, Dr. Mooney noted.`

Invited discussant Dr. Michael H. Levy, vice chair of medical oncology and director of the pain and palliative care program at Fox Chase Cancer Center in Philadelphia, commented that the SCP system “is interesting, but it’s very expensive, the impact is limited, and it’s challenging to export.”

He noted that for a palliative care support system to be implemented successfully, it would need to be reproducible and applicable to a wide range of health care systems.

The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

The study was supported by the National Cancer Institute. Dr. Mooney and Dr. Levy reported having no relevant disclosures.

BOSTON – An automated system for monitoring the symptoms of patients in home hospice and supporting their caregivers with coaching can both improve patient comfort and relieve at least some of the stress on the caregiver, said investigators in a pilot program.

In a prospective, randomized controlled trial, caregivers assigned to symptom care by phone, in which they received automated coaching tailored to the specific situation, had better overall vitality, and the patients they cared for had less fatigue and anxiety than caregiver-patient pairs assigned to usual care, reported Dr. Kathi Mooney, professor of nursing at the University of Utah College of Nursing, Salt Lake City.

“The family inclusion in hospice care, the philosophy around that, offers the opportunity to extend PROs [patient-reported outcomes] to FCROs, family caregiver reported outcomes. We call that an opportunity to use electronic monitoring to monitor a family,” she said at the Palliative Care in Oncology Symposium.

Dr. Mooney and her colleagues have previously reported on the use of automated symptom monitoring for support of patients undergoing ambulatory chemotherapy. In the current study, she described its application in home-based end-of-life care to support both the patient and the caregiver.

The investigators recruited 319 cancer patient/caregiver dyads from 12 hospices in Illinois, Massachusetts, Oregon, and Utah. The mean age of the patients was 72 years, and the mean age of caregivers was 59 years.

The caregivers were randomly assigned either to the symptom care by phone (SCP) system or to usual care. The SCP system is an automated system in which caregivers phone in to report the patient’s symptoms and their own levels of stress, anxiety, etc., and receive automated responses based on the severity of symptoms and number of days reported without relief. The system offers both patient care and self-care strategies, and identifies and reinforces issues that should be addressed by contacting the hospice team. At the end of the call, the data are sent to the nurse, including alerts to matters that require prompt attention.

Caregivers in each group made daily automated monitoring calls to report 1 or more of 11 patient symptoms and 5 caregiver symptoms on a 0-10 scale, and to report the patient’s and their own distress about the symptoms.

“We have developed algorithms to provide just-in-time, tailored suggestions related to the pattern that they have reported,” Dr. Mooney said.

Data reported by caregivers in the control (usual care) group were recorded but not acted upon, whereas data reported by those in the SCP intervention group triggered the automated coaching and hospice nurse alerts for moderate to severe symptoms.

“People in the usual care group understood that they were just contributing symptom information, and they were told on every call and at consent that if they had any concerns to call their hospice nurse,” Dr. Mooney said.

For clinicians, the automated system triggers an alert at preset thresholds of severity (4-10), as well as trend alerts. Hospice nurses have online and mobile access to the alert website, where they can view a report of symptoms over the previous 24 hours, and review graphs of symptoms over time to see trends. The nurses were instructed to log that they had seen the alert and what their planned action was, which was left to their professional judgment.

The average length of the calls was 7 minutes, 4 seconds for the usual care group, and 7 minutes, 59 seconds for the intervention group. Control group caregivers completed 59% of expected calls, and those in the intervention group completed 64%.

Reported symptoms present in more than 50% of patients included fatigue (88.8%), pain (60.2%), eating/drinking problems (76.6%), difficulty thinking (69.6%), anxiety (67.6%), negative mood (67.3%), bowel problems (61%), and trouble sleeping (58.3%).

Among caregivers, 73.3% reported fatigue, 66.7% anxiety, 61% trouble sleeping, and 57.1% negative mood.

In a mixed-effects model looking at caregiver vitality – a composite of caregiver symptoms – the authors found that the severity of symptoms in the usual care group increased steadily over the course of hospice care, out to at least 91 days. In contrast, the severity of symptoms among caregivers in the SCP group rose only slightly. The between-group difference was significant (P < .001).

Similarly, among patients the overall symptom severity scores were lower for those in the intervention group than for controls (P =.03). Additionally, the onset of benefit, defined as time to the first symptom-free day, was significantly earlier among patients in the SCP group (P < .02)

Patterns of patient and fatigue during the last 8 weeks of life also favored the symptom-care intervention, Dr. Mooney noted.`

Invited discussant Dr. Michael H. Levy, vice chair of medical oncology and director of the pain and palliative care program at Fox Chase Cancer Center in Philadelphia, commented that the SCP system “is interesting, but it’s very expensive, the impact is limited, and it’s challenging to export.”

He noted that for a palliative care support system to be implemented successfully, it would need to be reproducible and applicable to a wide range of health care systems.

The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

The study was supported by the National Cancer Institute. Dr. Mooney and Dr. Levy reported having no relevant disclosures.

BOSTON – An automated system for monitoring the symptoms of patients in home hospice and supporting their caregivers with coaching can both improve patient comfort and relieve at least some of the stress on the caregiver, said investigators in a pilot program.

In a prospective, randomized controlled trial, caregivers assigned to symptom care by phone, in which they received automated coaching tailored to the specific situation, had better overall vitality, and the patients they cared for had less fatigue and anxiety than caregiver-patient pairs assigned to usual care, reported Dr. Kathi Mooney, professor of nursing at the University of Utah College of Nursing, Salt Lake City.

“The family inclusion in hospice care, the philosophy around that, offers the opportunity to extend PROs [patient-reported outcomes] to FCROs, family caregiver reported outcomes. We call that an opportunity to use electronic monitoring to monitor a family,” she said at the Palliative Care in Oncology Symposium.

Dr. Mooney and her colleagues have previously reported on the use of automated symptom monitoring for support of patients undergoing ambulatory chemotherapy. In the current study, she described its application in home-based end-of-life care to support both the patient and the caregiver.

The investigators recruited 319 cancer patient/caregiver dyads from 12 hospices in Illinois, Massachusetts, Oregon, and Utah. The mean age of the patients was 72 years, and the mean age of caregivers was 59 years.

The caregivers were randomly assigned either to the symptom care by phone (SCP) system or to usual care. The SCP system is an automated system in which caregivers phone in to report the patient’s symptoms and their own levels of stress, anxiety, etc., and receive automated responses based on the severity of symptoms and number of days reported without relief. The system offers both patient care and self-care strategies, and identifies and reinforces issues that should be addressed by contacting the hospice team. At the end of the call, the data are sent to the nurse, including alerts to matters that require prompt attention.

Caregivers in each group made daily automated monitoring calls to report 1 or more of 11 patient symptoms and 5 caregiver symptoms on a 0-10 scale, and to report the patient’s and their own distress about the symptoms.

“We have developed algorithms to provide just-in-time, tailored suggestions related to the pattern that they have reported,” Dr. Mooney said.

Data reported by caregivers in the control (usual care) group were recorded but not acted upon, whereas data reported by those in the SCP intervention group triggered the automated coaching and hospice nurse alerts for moderate to severe symptoms.

“People in the usual care group understood that they were just contributing symptom information, and they were told on every call and at consent that if they had any concerns to call their hospice nurse,” Dr. Mooney said.

For clinicians, the automated system triggers an alert at preset thresholds of severity (4-10), as well as trend alerts. Hospice nurses have online and mobile access to the alert website, where they can view a report of symptoms over the previous 24 hours, and review graphs of symptoms over time to see trends. The nurses were instructed to log that they had seen the alert and what their planned action was, which was left to their professional judgment.

The average length of the calls was 7 minutes, 4 seconds for the usual care group, and 7 minutes, 59 seconds for the intervention group. Control group caregivers completed 59% of expected calls, and those in the intervention group completed 64%.

Reported symptoms present in more than 50% of patients included fatigue (88.8%), pain (60.2%), eating/drinking problems (76.6%), difficulty thinking (69.6%), anxiety (67.6%), negative mood (67.3%), bowel problems (61%), and trouble sleeping (58.3%).

Among caregivers, 73.3% reported fatigue, 66.7% anxiety, 61% trouble sleeping, and 57.1% negative mood.

In a mixed-effects model looking at caregiver vitality – a composite of caregiver symptoms – the authors found that the severity of symptoms in the usual care group increased steadily over the course of hospice care, out to at least 91 days. In contrast, the severity of symptoms among caregivers in the SCP group rose only slightly. The between-group difference was significant (P < .001).

Similarly, among patients the overall symptom severity scores were lower for those in the intervention group than for controls (P =.03). Additionally, the onset of benefit, defined as time to the first symptom-free day, was significantly earlier among patients in the SCP group (P < .02)

Patterns of patient and fatigue during the last 8 weeks of life also favored the symptom-care intervention, Dr. Mooney noted.`

Invited discussant Dr. Michael H. Levy, vice chair of medical oncology and director of the pain and palliative care program at Fox Chase Cancer Center in Philadelphia, commented that the SCP system “is interesting, but it’s very expensive, the impact is limited, and it’s challenging to export.”

He noted that for a palliative care support system to be implemented successfully, it would need to be reproducible and applicable to a wide range of health care systems.

The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

The study was supported by the National Cancer Institute. Dr. Mooney and Dr. Levy reported having no relevant disclosures.

The risk of recurrence (ROR) score provides clinically meaningful prognostic information after postmenopausal women with early-stage breast cancer complete 5 years of tamoxifen therapy, according to a report published online Oct. 27 in Journal of Clinical Oncology.

The ROR score is derived from a quantitative assessment of a tumor’s expression of 46 genes related to breast cancer plus a measure of the tumor’s size. In this study, it was added to the Clinical Treatment Score, a standard prognostic tool that takes into account nodal status, tumor size and grade, patient age, and treatment modalities, said Ivana Sestak, Ph.D., of the Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University, London, and her associates.

To examine the usefulness of the ROR score in assessing risk for late recurrence of breast cancer, researchers analyzed combined data from two large clinical trials involving 2,137 postmenopausal women with early-stage hormone receptor–positive breast cancer who received 5 years of endocrine therapy but no chemotherapy and were followed for a further 5 years. There were 148 distant recurrences during that time.

Women classified by ROR score as high risk were 6.9 times more likely to develop a late recurrence than were those classified as low risk, and women classified by ROR score as intermediate risk were 3.3 times more likely to develop a late recurrence. The addition of ROR score to the Clinical Treatment Score reclassified 32 women as high risk, and those women did go on to develop a late recurrence. Similarly, adding to ROR score to the Clinical Treatment Score reclassified three women as low risk, and those women did not go on to develop a late recurrence, the investigators said (J. Clin. Oncol. 2014 Oct. 27 [doi:10.1200/JCO.2014.55.6894]).

In particular, the ROR score was helpful in assigning a “low-risk” designation to women who had node-negative and node-negative/HER2-negative disease, even though some of them had large tumors. These women could safely be spared from further endocrine therapy. Likewise, the ROR score was helpful in identifying women at high risk of recurrence who may wish to extend endocrine therapy beyond 5 years, Dr. Sestak and her associates said.

The risk of recurrence (ROR) score provides clinically meaningful prognostic information after postmenopausal women with early-stage breast cancer complete 5 years of tamoxifen therapy, according to a report published online Oct. 27 in Journal of Clinical Oncology.

The ROR score is derived from a quantitative assessment of a tumor’s expression of 46 genes related to breast cancer plus a measure of the tumor’s size. In this study, it was added to the Clinical Treatment Score, a standard prognostic tool that takes into account nodal status, tumor size and grade, patient age, and treatment modalities, said Ivana Sestak, Ph.D., of the Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University, London, and her associates.

To examine the usefulness of the ROR score in assessing risk for late recurrence of breast cancer, researchers analyzed combined data from two large clinical trials involving 2,137 postmenopausal women with early-stage hormone receptor–positive breast cancer who received 5 years of endocrine therapy but no chemotherapy and were followed for a further 5 years. There were 148 distant recurrences during that time.

Women classified by ROR score as high risk were 6.9 times more likely to develop a late recurrence than were those classified as low risk, and women classified by ROR score as intermediate risk were 3.3 times more likely to develop a late recurrence. The addition of ROR score to the Clinical Treatment Score reclassified 32 women as high risk, and those women did go on to develop a late recurrence. Similarly, adding to ROR score to the Clinical Treatment Score reclassified three women as low risk, and those women did not go on to develop a late recurrence, the investigators said (J. Clin. Oncol. 2014 Oct. 27 [doi:10.1200/JCO.2014.55.6894]).

In particular, the ROR score was helpful in assigning a “low-risk” designation to women who had node-negative and node-negative/HER2-negative disease, even though some of them had large tumors. These women could safely be spared from further endocrine therapy. Likewise, the ROR score was helpful in identifying women at high risk of recurrence who may wish to extend endocrine therapy beyond 5 years, Dr. Sestak and her associates said.

The risk of recurrence (ROR) score provides clinically meaningful prognostic information after postmenopausal women with early-stage breast cancer complete 5 years of tamoxifen therapy, according to a report published online Oct. 27 in Journal of Clinical Oncology.

The ROR score is derived from a quantitative assessment of a tumor’s expression of 46 genes related to breast cancer plus a measure of the tumor’s size. In this study, it was added to the Clinical Treatment Score, a standard prognostic tool that takes into account nodal status, tumor size and grade, patient age, and treatment modalities, said Ivana Sestak, Ph.D., of the Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University, London, and her associates.

To examine the usefulness of the ROR score in assessing risk for late recurrence of breast cancer, researchers analyzed combined data from two large clinical trials involving 2,137 postmenopausal women with early-stage hormone receptor–positive breast cancer who received 5 years of endocrine therapy but no chemotherapy and were followed for a further 5 years. There were 148 distant recurrences during that time.

Women classified by ROR score as high risk were 6.9 times more likely to develop a late recurrence than were those classified as low risk, and women classified by ROR score as intermediate risk were 3.3 times more likely to develop a late recurrence. The addition of ROR score to the Clinical Treatment Score reclassified 32 women as high risk, and those women did go on to develop a late recurrence. Similarly, adding to ROR score to the Clinical Treatment Score reclassified three women as low risk, and those women did not go on to develop a late recurrence, the investigators said (J. Clin. Oncol. 2014 Oct. 27 [doi:10.1200/JCO.2014.55.6894]).

In particular, the ROR score was helpful in assigning a “low-risk” designation to women who had node-negative and node-negative/HER2-negative disease, even though some of them had large tumors. These women could safely be spared from further endocrine therapy. Likewise, the ROR score was helpful in identifying women at high risk of recurrence who may wish to extend endocrine therapy beyond 5 years, Dr. Sestak and her associates said.

BOSTON – What clinicians see and what patients feel may be two different things, but optimal care for patients with cancer depends on smooth two-way communication between patients who are sometimes afraid to be a bother, and caregivers who sometimes fail to pick up on patient distress, said an investigator who studied patient-reported outcomes.

“We really have a propensity to underestimate symptoms – not only the incidence, but also the severity of the symptom, and also what type of distress that symptom is causing for that individual patient,” said Jeannine M. Brant, Ph.D., an oncology nurse specialist and nurse scientist at the Billings (Mont.) Clinic. “We need to incorporate PROs [patient-reported outcomes] into our clinical practice,” she said at the inaugural American Society of Clinical Oncology (ASCO) Palliative Care Symposium.

She and her colleagues were recently surprised, she said, when an otherwise healthy-looking rectal cancer survivor, an avid runner, reported having a high level of distress due to unpredictable bouts of diarrhea and fatigue. The patient said she had not reported the symptoms earlier because they seemed to be “a small trade-off for having my life back.”

With the help of the support team, which provided nutritional consultation and antidiarrheal agents, the patient was soon back on her feet and running again, and reported a high quality of life.

The case “points out the need to ask patients about their symptoms, because if we don’t ask about them, we’re not going to know what they’re experiencing,” Dr. Brant said.

ASCO’s Quality Oncology Practice Initiative (QOPI) calls for starting the PRO process before the first administration of a new chemotherapy regimen. In addition, it calls for an assessment of the patient’s psychosocial concerns and needs, with appropriate action taken when indicated, at each clinical visit or treatment day during a chemotherapy regimen.

Barriers to PROs

Patients may be selective about what they report to their caregivers, with reasons that may include the desire to be a “good” patient, willingness to exchange some discomfort or unpleasant symptoms for better disease control, a fear that their symptoms might halt or interrupt their treatment, limited time spent with their clinicians, the perception that nothing can be done to control symptoms, or sheer embarrassment.

On the clinical side, physicians and nurses may have gaps in their knowledge and attitudes about symptoms, or may fail to ask because they are short on time and are concerned that having a discussion of symptoms will “open a can of worms” that they will then have to deal with. Additionally, clinicians may be hampered by the lack of a consistent process for integrating PROs into the electronic health records, Dr. Brant said.

There are currently several electronic platforms that can help to automate and simplify the PRO report process. In general, the systems allow patients to report physical, social, functional, and quality of life symptoms, and help clinicians assess satisfaction with treatment, how well the patient is coping, and treatment adherence. Some systems offer tips to patients about what to report and how to best frame it during their clinic visit.

Capturing toxicities

The National Cancer Institute is currently developing a PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), to be used in tandem with the CTCAE, Dr. Brant noted.

Drawing on a symptoms library of 78 adverse events from the CTCAE, the PRO-CTCAE contains questions for evaluating symptom occurrence, frequency, severity, and interference. Patients can respond online, with computer tablets, or via an interactive voice response telephone system. Based on the responses, the system can assign a severity grade and record events for review by clinicians.

“This is looking at the patient experience and not trying simply to decide what the patient is experiencing as a result of a drug,” Dr. Brant said.

Automated care plan

Dr. Brant also described her experience with a semiautomated care planning system (On Q), which uses patient-reported data and clinical data to generate a customized draft patient care plan incorporating oncology quality standards, guidelines, and current research.

The system can generate supportive care plans that offer specific recommendations about distress screening, survivorship care, surveillance, and follow-up.

In a pilot study of the system with 23 breast cancer patients at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, and 18 patients with gynecologic cancers at the Billings Clinic, more than 90% of patients reported being satisfied with the system and said they would recommend it to others. Patients received a copy of the care plan on a flash drive or on paper if they preferred.

One patient commented that “the care plan reminds you to bring up issues, guides the discussion, and gives doctors a better overall picture of what’s going on with you.”

The study funding source was not reported. Dr. Brant disclosed receiving honoraria and serving on the speakers bureau of Genentech.

BOSTON – What clinicians see and what patients feel may be two different things, but optimal care for patients with cancer depends on smooth two-way communication between patients who are sometimes afraid to be a bother, and caregivers who sometimes fail to pick up on patient distress, said an investigator who studied patient-reported outcomes.

“We really have a propensity to underestimate symptoms – not only the incidence, but also the severity of the symptom, and also what type of distress that symptom is causing for that individual patient,” said Jeannine M. Brant, Ph.D., an oncology nurse specialist and nurse scientist at the Billings (Mont.) Clinic. “We need to incorporate PROs [patient-reported outcomes] into our clinical practice,” she said at the inaugural American Society of Clinical Oncology (ASCO) Palliative Care Symposium.

She and her colleagues were recently surprised, she said, when an otherwise healthy-looking rectal cancer survivor, an avid runner, reported having a high level of distress due to unpredictable bouts of diarrhea and fatigue. The patient said she had not reported the symptoms earlier because they seemed to be “a small trade-off for having my life back.”

With the help of the support team, which provided nutritional consultation and antidiarrheal agents, the patient was soon back on her feet and running again, and reported a high quality of life.

The case “points out the need to ask patients about their symptoms, because if we don’t ask about them, we’re not going to know what they’re experiencing,” Dr. Brant said.

ASCO’s Quality Oncology Practice Initiative (QOPI) calls for starting the PRO process before the first administration of a new chemotherapy regimen. In addition, it calls for an assessment of the patient’s psychosocial concerns and needs, with appropriate action taken when indicated, at each clinical visit or treatment day during a chemotherapy regimen.

Barriers to PROs

Patients may be selective about what they report to their caregivers, with reasons that may include the desire to be a “good” patient, willingness to exchange some discomfort or unpleasant symptoms for better disease control, a fear that their symptoms might halt or interrupt their treatment, limited time spent with their clinicians, the perception that nothing can be done to control symptoms, or sheer embarrassment.

On the clinical side, physicians and nurses may have gaps in their knowledge and attitudes about symptoms, or may fail to ask because they are short on time and are concerned that having a discussion of symptoms will “open a can of worms” that they will then have to deal with. Additionally, clinicians may be hampered by the lack of a consistent process for integrating PROs into the electronic health records, Dr. Brant said.

There are currently several electronic platforms that can help to automate and simplify the PRO report process. In general, the systems allow patients to report physical, social, functional, and quality of life symptoms, and help clinicians assess satisfaction with treatment, how well the patient is coping, and treatment adherence. Some systems offer tips to patients about what to report and how to best frame it during their clinic visit.

Capturing toxicities

The National Cancer Institute is currently developing a PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), to be used in tandem with the CTCAE, Dr. Brant noted.

Drawing on a symptoms library of 78 adverse events from the CTCAE, the PRO-CTCAE contains questions for evaluating symptom occurrence, frequency, severity, and interference. Patients can respond online, with computer tablets, or via an interactive voice response telephone system. Based on the responses, the system can assign a severity grade and record events for review by clinicians.

“This is looking at the patient experience and not trying simply to decide what the patient is experiencing as a result of a drug,” Dr. Brant said.

Automated care plan

Dr. Brant also described her experience with a semiautomated care planning system (On Q), which uses patient-reported data and clinical data to generate a customized draft patient care plan incorporating oncology quality standards, guidelines, and current research.

The system can generate supportive care plans that offer specific recommendations about distress screening, survivorship care, surveillance, and follow-up.

In a pilot study of the system with 23 breast cancer patients at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, and 18 patients with gynecologic cancers at the Billings Clinic, more than 90% of patients reported being satisfied with the system and said they would recommend it to others. Patients received a copy of the care plan on a flash drive or on paper if they preferred.

One patient commented that “the care plan reminds you to bring up issues, guides the discussion, and gives doctors a better overall picture of what’s going on with you.”

The study funding source was not reported. Dr. Brant disclosed receiving honoraria and serving on the speakers bureau of Genentech.

BOSTON – What clinicians see and what patients feel may be two different things, but optimal care for patients with cancer depends on smooth two-way communication between patients who are sometimes afraid to be a bother, and caregivers who sometimes fail to pick up on patient distress, said an investigator who studied patient-reported outcomes.

“We really have a propensity to underestimate symptoms – not only the incidence, but also the severity of the symptom, and also what type of distress that symptom is causing for that individual patient,” said Jeannine M. Brant, Ph.D., an oncology nurse specialist and nurse scientist at the Billings (Mont.) Clinic. “We need to incorporate PROs [patient-reported outcomes] into our clinical practice,” she said at the inaugural American Society of Clinical Oncology (ASCO) Palliative Care Symposium.

She and her colleagues were recently surprised, she said, when an otherwise healthy-looking rectal cancer survivor, an avid runner, reported having a high level of distress due to unpredictable bouts of diarrhea and fatigue. The patient said she had not reported the symptoms earlier because they seemed to be “a small trade-off for having my life back.”

With the help of the support team, which provided nutritional consultation and antidiarrheal agents, the patient was soon back on her feet and running again, and reported a high quality of life.

The case “points out the need to ask patients about their symptoms, because if we don’t ask about them, we’re not going to know what they’re experiencing,” Dr. Brant said.

ASCO’s Quality Oncology Practice Initiative (QOPI) calls for starting the PRO process before the first administration of a new chemotherapy regimen. In addition, it calls for an assessment of the patient’s psychosocial concerns and needs, with appropriate action taken when indicated, at each clinical visit or treatment day during a chemotherapy regimen.

Barriers to PROs

Patients may be selective about what they report to their caregivers, with reasons that may include the desire to be a “good” patient, willingness to exchange some discomfort or unpleasant symptoms for better disease control, a fear that their symptoms might halt or interrupt their treatment, limited time spent with their clinicians, the perception that nothing can be done to control symptoms, or sheer embarrassment.

On the clinical side, physicians and nurses may have gaps in their knowledge and attitudes about symptoms, or may fail to ask because they are short on time and are concerned that having a discussion of symptoms will “open a can of worms” that they will then have to deal with. Additionally, clinicians may be hampered by the lack of a consistent process for integrating PROs into the electronic health records, Dr. Brant said.

There are currently several electronic platforms that can help to automate and simplify the PRO report process. In general, the systems allow patients to report physical, social, functional, and quality of life symptoms, and help clinicians assess satisfaction with treatment, how well the patient is coping, and treatment adherence. Some systems offer tips to patients about what to report and how to best frame it during their clinic visit.

Capturing toxicities

The National Cancer Institute is currently developing a PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), to be used in tandem with the CTCAE, Dr. Brant noted.

Drawing on a symptoms library of 78 adverse events from the CTCAE, the PRO-CTCAE contains questions for evaluating symptom occurrence, frequency, severity, and interference. Patients can respond online, with computer tablets, or via an interactive voice response telephone system. Based on the responses, the system can assign a severity grade and record events for review by clinicians.

“This is looking at the patient experience and not trying simply to decide what the patient is experiencing as a result of a drug,” Dr. Brant said.

Automated care plan

Dr. Brant also described her experience with a semiautomated care planning system (On Q), which uses patient-reported data and clinical data to generate a customized draft patient care plan incorporating oncology quality standards, guidelines, and current research.

The system can generate supportive care plans that offer specific recommendations about distress screening, survivorship care, surveillance, and follow-up.

In a pilot study of the system with 23 breast cancer patients at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, and 18 patients with gynecologic cancers at the Billings Clinic, more than 90% of patients reported being satisfied with the system and said they would recommend it to others. Patients received a copy of the care plan on a flash drive or on paper if they preferred.

One patient commented that “the care plan reminds you to bring up issues, guides the discussion, and gives doctors a better overall picture of what’s going on with you.”

The study funding source was not reported. Dr. Brant disclosed receiving honoraria and serving on the speakers bureau of Genentech.

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

[email protected]

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – Relizen, a nonhormonal purified pollen extract with demonstrated efficacy in treating vasomotor symptoms of menopause, had negligible effects on the CYP2D6 enzyme at five times the recommended daily dose, according to a poster presentation.

Because tamoxifen is metabolized into endoxifen, the active metabolite in the CYP2D6 enzyme, the findings could mean women with severe hot flashes who are taking tamoxifen now have a viable treatment option that won’t increase their risk of death from breast cancer.

“Tamoxifen creates some of the worst hot flashes we will ever see,” Dr. Steven R. Goldstein, professor of obstetrics and gynecology at New York University, said in an interview at this year’s annual meeting of the North American Menopause Society. Even so, because systemic estrogen is contraindicated in women using either tamoxifen or raloxifene for the treatment or chemoprevention of breast cancer, and questions remain about the safety of phytoestrogens, many of these women forgo the commonly prescribed estrogen-based treatments for menopausal symptoms.

Instead, some physicians will prescribe off-label low doses of antidepressants to treat vasomotor symptoms in this patient population. However, a 2010 population-based cohort study of 2,430 Canadian women taking tamoxifen concurrently with an SSRI showed that the risk of death from breast cancer increased 24%-91% in those taking paroxetine in particular, depending on the increasing overlap of tamoxifen treatment and antidepressant use (BMJ 2010;340:c693 [doi:10.1136/bmj.c693]). Last year, the Food and Drug Administration approved the vasomotor symptoms of menopause as an indication for the SSRI paroxetine (Paxil, Brisdelle), but required Noven, the drug’s manufacturer, to state paroxetine’s countering effect on tamoxifen’s efficacy.

Until now, according to Dr. Goldstein, fears over estrogen and SSRI’s potential ill-effects have meant that many women have chosen to “tough it out” when it comes to hot flashes, night sweats, and other symptoms.

The importance of his study, he said, is that because Relizen (Sérélyspharma, France), a powdered, pollen cytoplasmic extract harvested in southern Sweden, doesn’t affect the CYP enzyme system, it’s safe to give to tamoxifen patients. “It is the only nonpharmacologic product that I have ever been aware of that has a double-blind, randomized, placebo-controlled, parallel study showing that it reduces vasomotor symptoms and improves quality of life in menopausal women,” Dr. Goldstein said.

In an in vitro study of Relizen’s effect on the isoenzyme CYP2D6 in pooled human liver microsomes, Dr. Goldstein and his colleagues tested the supplement against quinidine, a known CYP2D6 inhibitor. The end point was the conversion of bufuralol to 1-OH-bufuralol in the CYP enzyme system. Six concentrations of each compound were tested, with all reactions being performed in triplicate. The Relizen concentrations ranged from 1.65 mcg/mL to 400 mcg/mL, five times the Relizen recommended daily dose of 80 mcg/mL. The quinidine concentrations ranged from 2.06 nM to 500 nM.

The study compound’s inhibition of CYP2D6 was negligible, ranging from –6.53% to 10.67%, compared with quinidine’s CYP2D6 linear dose-related increase from –7.07% at 2.06 nM to 84.05% at 500 nM.

Relizen’s apparent clinical utility in women at high risk of death from breast cancer is the “low-hanging fruit,” Dr. Goldstein said. “The tamoxifen patient has no other place to go. But if a woman is 51 years old and she comes to me and says she has hot flashes, now I have multiple options. I can give her hormones, I can give her 7.5 mg of paroxetine, or I can give her Relizen. This is just another arrow in my quiver.”

In the placebo-controlled study of Relizen, 65% of the active treatment group of 32 peri- and postmenopausal women reported decreased vasomotor symptoms by the end of the 12 week trial, compared with 38% of the placebo group (Climacteric 2005; 8:162-70).

“I know [Relizen] is effective, and it’s tested against placebo,” Dr. Goldstein said. “But is it as strong as estrogen? I have no clue. A head-to-head trial is not going to happen.”

Relizen has been widely available in Europe under a variety of names, including Femal, since 1999, and has had no reported adverse effects, according to the manufacturer. JDS Pharmaceuticals (Noven) began distributing the supplement in the United States earlier this year.

Dr. Goldstein is a paid consultant for JDS Pharmaceuticals, a division of Noven. The study was sponsored by the supplement manufacturer, Sérélyspharma(France). JDS Pharmaceuticals (Noven) is the licensed distributor of Relizen in the United States.

[email protected]

On Twitter @whitneymcknight