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Help for Active Surveillance Anxiety in Men with Prostate Cancer

Study Overview

Objective. To examine the feasibility, acceptability and benefits of mindfulness meditation training in men with low-grade prostate cancer on active surveillance.

Design. Randomized controlled pilot trial.

Setting and participants. Participants were men with low-risk localized prostate cancer who were on an IRB-approved active surveillance protocol within a medium-sized community hospital system in suburban Chicago. Enrolled patients were randomized to the active intervention or a control condition where participants received a book on mindfulness but no specific instructions to read it.

Intervention. Patients in the intervention arm attended an 8-week mindfulness-based stress reduction intervention, consisting of weekly sessions lasting 2½ hours held at their local primary hospital. Sessions were conducted by a trained and experienced mindfulness instructor. The intervention also included a half day retreat near the end of the intervention period to practice the skills that were taught.

Main outcome measures. Main outcome measures were prostate cancer anxiety (measured using the 18-item Memorial Anxiety Scale for Prostate Cancer), uncertainty tolerance (measured using the 12-item Intolerance of Uncertainty Short Form), mindfulness (measured via the 15-item Mindful Attention Awareness Scale), and health-related quality of life (measured using 10-item PROMIS Global Health-10). Researchers also measured “posttraumatic growth” using the Posttraumatic Growth Inventory, a 21-item self-report scale used to assess growth or benefits after a specific traumatic life event, such as a diagnosis of cancer. Participants completed instruments at baseline, 8 weeks, 6 months, and 12 months. At 12 months they also complete a brief feasibility and acceptance survey.

Main results. Over a 3-year period, 115 men were approached to participate and 54 enrolled. 11 withdrew prior to randomization citing lack of time as the primary reason. Ultimately, 24 men were randomized to the mindfulness arm and 19 to control. Average age was 70 years and 95% were white. Over 90% had never previously meditated or had never meditated on a regular basis. There were no significant differences between enrollees and decliners on baseline clinical or sociodemographic variables, and there were no significant differences between mindfulness and control patients on sociodemographic or clinical variables or outcome measures.

Participants in the intervention group reported decreased prostate cancer anxiety at 6 months (P = 0.02, effect size ([ES] 0.30) and uncertainty intolerance at 12 months (P = 0.02, ES 0.32) and increased quality of life at 8 weeks (P = 0.05, ES 0.17), mindfulness at 8 weeks (P < 0.04, ES 0.35) and 12 months (P < 0.01, ES 0.17), and posttraumatic growth (P < 0.05 for all follow-up measurements). When measuring changes between the groups, the only outcome that was significant was posttraumatic growth (P = 0.01, ES 0.73). Written responses to the open-ended survey questions regarding participants’ experience with the course cited increased emotional regulation and self-awareness and positive health behavior change.

Conclusion. An 8-week mindfulness training is feasible and acceptable to men with prostate cancer on active surveillance and may help men cope more effectively with stress and anxiety related to their cancer experience.

Commentary

Prostate cancer is the most common nonskin malignancy in men. More than 180,000 men are diagnosed per year, with over 26,000 prostate cancer deaths annually [1]. The optimal approach to treating newly diagnosed prostate cancer can be variable, but for most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, active surveillance is the recommended disease management strategy [2]. Despite the favorable prognosis of low-risk prostate cancer, men who choose active surveillance may experience anxiety and uncertainty, which can cause many to request definitive therapy even when there is no tumor progression [3].

Mindfulness-based meditation is a practice that is increasingly being investigated for a wide array of health conditions. Mindfulness has been defined as being intentionally aware of internal and external experiences that occur at the present moment, without judgment. Behavioral interventions such as mindfulness training may lessen anxiety related to uncertainty intolerance and help maintain patient engagement in active surveillance [4].

This small pilot study by Victorson et al evaluated an 8-week mindfulness meditation intervention intended to help men in active surveillance manage cancer-related uncertainty intolerance. They found the meditation training to be generally feasible and acceptable among participants. Men in the active intervention demonstrated statistically significant within-group changes that included decreased prostate cancer anxiety and increased mental well-being and posttraumatic growth, but there were no differences between groups except for posttraumatic growth. Interestingly, the control group also reported a moderate increase in mindfulness at 12 months, which was found (in an exploratory follow-up analysis) to be unrelated to reading the mindfulness book they were given (eg, those who did not open the book had higher average mindfulness scores than those who read the book from cover to cover).

Limitations of the study include the small sample size and lack of diversity among the participants, who were 95% white and well educated. In addition, the response rate prior to randomization was low: out of 115 men approached, 43 were ultimately randomized. Retention rates at 12 months were similar: 71% for intervention and 74% for control.

Applications for Clinical Practice

A growing body of research demonstrates that mindfulness practice may aid in improving psychological well-being. Further research is necessary before a clinical recommendation can be offered regarding use of mindfulness instruction to alleviate anxiety in men with low-grade prostate cancer being managed with active surveillance.

References

1.  Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016;66:7-–30.

2.  Chen RC, Rumble RB, Loblaw DA, et al. Active surveillance for the management of localized prostate cancer (Cancer Care Ontario Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol 2016;34:2182–90.

3.  Latini DM, Hart SL, Knight SJ, et al; CaPSURE Investigators. The relationship between anxiety and time to treatment for patients with prostate cancer on surveillance. J Urol 2007;178(3 Pt 1):826–31; discussion 831–2.

4.  Tan HJ, Marks LS, Hoyt MA, et al. The relationship between intolerance of uncertainty and anxiety in men on active surveillance for prostate cancer. J Urol 2016;195:1724–30.

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Journal of Clinical Outcomes Management - July 2016, VOL. 23, NO. 7
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Study Overview

Objective. To examine the feasibility, acceptability and benefits of mindfulness meditation training in men with low-grade prostate cancer on active surveillance.

Design. Randomized controlled pilot trial.

Setting and participants. Participants were men with low-risk localized prostate cancer who were on an IRB-approved active surveillance protocol within a medium-sized community hospital system in suburban Chicago. Enrolled patients were randomized to the active intervention or a control condition where participants received a book on mindfulness but no specific instructions to read it.

Intervention. Patients in the intervention arm attended an 8-week mindfulness-based stress reduction intervention, consisting of weekly sessions lasting 2½ hours held at their local primary hospital. Sessions were conducted by a trained and experienced mindfulness instructor. The intervention also included a half day retreat near the end of the intervention period to practice the skills that were taught.

Main outcome measures. Main outcome measures were prostate cancer anxiety (measured using the 18-item Memorial Anxiety Scale for Prostate Cancer), uncertainty tolerance (measured using the 12-item Intolerance of Uncertainty Short Form), mindfulness (measured via the 15-item Mindful Attention Awareness Scale), and health-related quality of life (measured using 10-item PROMIS Global Health-10). Researchers also measured “posttraumatic growth” using the Posttraumatic Growth Inventory, a 21-item self-report scale used to assess growth or benefits after a specific traumatic life event, such as a diagnosis of cancer. Participants completed instruments at baseline, 8 weeks, 6 months, and 12 months. At 12 months they also complete a brief feasibility and acceptance survey.

Main results. Over a 3-year period, 115 men were approached to participate and 54 enrolled. 11 withdrew prior to randomization citing lack of time as the primary reason. Ultimately, 24 men were randomized to the mindfulness arm and 19 to control. Average age was 70 years and 95% were white. Over 90% had never previously meditated or had never meditated on a regular basis. There were no significant differences between enrollees and decliners on baseline clinical or sociodemographic variables, and there were no significant differences between mindfulness and control patients on sociodemographic or clinical variables or outcome measures.

Participants in the intervention group reported decreased prostate cancer anxiety at 6 months (P = 0.02, effect size ([ES] 0.30) and uncertainty intolerance at 12 months (P = 0.02, ES 0.32) and increased quality of life at 8 weeks (P = 0.05, ES 0.17), mindfulness at 8 weeks (P < 0.04, ES 0.35) and 12 months (P < 0.01, ES 0.17), and posttraumatic growth (P < 0.05 for all follow-up measurements). When measuring changes between the groups, the only outcome that was significant was posttraumatic growth (P = 0.01, ES 0.73). Written responses to the open-ended survey questions regarding participants’ experience with the course cited increased emotional regulation and self-awareness and positive health behavior change.

Conclusion. An 8-week mindfulness training is feasible and acceptable to men with prostate cancer on active surveillance and may help men cope more effectively with stress and anxiety related to their cancer experience.

Commentary

Prostate cancer is the most common nonskin malignancy in men. More than 180,000 men are diagnosed per year, with over 26,000 prostate cancer deaths annually [1]. The optimal approach to treating newly diagnosed prostate cancer can be variable, but for most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, active surveillance is the recommended disease management strategy [2]. Despite the favorable prognosis of low-risk prostate cancer, men who choose active surveillance may experience anxiety and uncertainty, which can cause many to request definitive therapy even when there is no tumor progression [3].

Mindfulness-based meditation is a practice that is increasingly being investigated for a wide array of health conditions. Mindfulness has been defined as being intentionally aware of internal and external experiences that occur at the present moment, without judgment. Behavioral interventions such as mindfulness training may lessen anxiety related to uncertainty intolerance and help maintain patient engagement in active surveillance [4].

This small pilot study by Victorson et al evaluated an 8-week mindfulness meditation intervention intended to help men in active surveillance manage cancer-related uncertainty intolerance. They found the meditation training to be generally feasible and acceptable among participants. Men in the active intervention demonstrated statistically significant within-group changes that included decreased prostate cancer anxiety and increased mental well-being and posttraumatic growth, but there were no differences between groups except for posttraumatic growth. Interestingly, the control group also reported a moderate increase in mindfulness at 12 months, which was found (in an exploratory follow-up analysis) to be unrelated to reading the mindfulness book they were given (eg, those who did not open the book had higher average mindfulness scores than those who read the book from cover to cover).

Limitations of the study include the small sample size and lack of diversity among the participants, who were 95% white and well educated. In addition, the response rate prior to randomization was low: out of 115 men approached, 43 were ultimately randomized. Retention rates at 12 months were similar: 71% for intervention and 74% for control.

Applications for Clinical Practice

A growing body of research demonstrates that mindfulness practice may aid in improving psychological well-being. Further research is necessary before a clinical recommendation can be offered regarding use of mindfulness instruction to alleviate anxiety in men with low-grade prostate cancer being managed with active surveillance.

Study Overview

Objective. To examine the feasibility, acceptability and benefits of mindfulness meditation training in men with low-grade prostate cancer on active surveillance.

Design. Randomized controlled pilot trial.

Setting and participants. Participants were men with low-risk localized prostate cancer who were on an IRB-approved active surveillance protocol within a medium-sized community hospital system in suburban Chicago. Enrolled patients were randomized to the active intervention or a control condition where participants received a book on mindfulness but no specific instructions to read it.

Intervention. Patients in the intervention arm attended an 8-week mindfulness-based stress reduction intervention, consisting of weekly sessions lasting 2½ hours held at their local primary hospital. Sessions were conducted by a trained and experienced mindfulness instructor. The intervention also included a half day retreat near the end of the intervention period to practice the skills that were taught.

Main outcome measures. Main outcome measures were prostate cancer anxiety (measured using the 18-item Memorial Anxiety Scale for Prostate Cancer), uncertainty tolerance (measured using the 12-item Intolerance of Uncertainty Short Form), mindfulness (measured via the 15-item Mindful Attention Awareness Scale), and health-related quality of life (measured using 10-item PROMIS Global Health-10). Researchers also measured “posttraumatic growth” using the Posttraumatic Growth Inventory, a 21-item self-report scale used to assess growth or benefits after a specific traumatic life event, such as a diagnosis of cancer. Participants completed instruments at baseline, 8 weeks, 6 months, and 12 months. At 12 months they also complete a brief feasibility and acceptance survey.

Main results. Over a 3-year period, 115 men were approached to participate and 54 enrolled. 11 withdrew prior to randomization citing lack of time as the primary reason. Ultimately, 24 men were randomized to the mindfulness arm and 19 to control. Average age was 70 years and 95% were white. Over 90% had never previously meditated or had never meditated on a regular basis. There were no significant differences between enrollees and decliners on baseline clinical or sociodemographic variables, and there were no significant differences between mindfulness and control patients on sociodemographic or clinical variables or outcome measures.

Participants in the intervention group reported decreased prostate cancer anxiety at 6 months (P = 0.02, effect size ([ES] 0.30) and uncertainty intolerance at 12 months (P = 0.02, ES 0.32) and increased quality of life at 8 weeks (P = 0.05, ES 0.17), mindfulness at 8 weeks (P < 0.04, ES 0.35) and 12 months (P < 0.01, ES 0.17), and posttraumatic growth (P < 0.05 for all follow-up measurements). When measuring changes between the groups, the only outcome that was significant was posttraumatic growth (P = 0.01, ES 0.73). Written responses to the open-ended survey questions regarding participants’ experience with the course cited increased emotional regulation and self-awareness and positive health behavior change.

Conclusion. An 8-week mindfulness training is feasible and acceptable to men with prostate cancer on active surveillance and may help men cope more effectively with stress and anxiety related to their cancer experience.

Commentary

Prostate cancer is the most common nonskin malignancy in men. More than 180,000 men are diagnosed per year, with over 26,000 prostate cancer deaths annually [1]. The optimal approach to treating newly diagnosed prostate cancer can be variable, but for most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, active surveillance is the recommended disease management strategy [2]. Despite the favorable prognosis of low-risk prostate cancer, men who choose active surveillance may experience anxiety and uncertainty, which can cause many to request definitive therapy even when there is no tumor progression [3].

Mindfulness-based meditation is a practice that is increasingly being investigated for a wide array of health conditions. Mindfulness has been defined as being intentionally aware of internal and external experiences that occur at the present moment, without judgment. Behavioral interventions such as mindfulness training may lessen anxiety related to uncertainty intolerance and help maintain patient engagement in active surveillance [4].

This small pilot study by Victorson et al evaluated an 8-week mindfulness meditation intervention intended to help men in active surveillance manage cancer-related uncertainty intolerance. They found the meditation training to be generally feasible and acceptable among participants. Men in the active intervention demonstrated statistically significant within-group changes that included decreased prostate cancer anxiety and increased mental well-being and posttraumatic growth, but there were no differences between groups except for posttraumatic growth. Interestingly, the control group also reported a moderate increase in mindfulness at 12 months, which was found (in an exploratory follow-up analysis) to be unrelated to reading the mindfulness book they were given (eg, those who did not open the book had higher average mindfulness scores than those who read the book from cover to cover).

Limitations of the study include the small sample size and lack of diversity among the participants, who were 95% white and well educated. In addition, the response rate prior to randomization was low: out of 115 men approached, 43 were ultimately randomized. Retention rates at 12 months were similar: 71% for intervention and 74% for control.

Applications for Clinical Practice

A growing body of research demonstrates that mindfulness practice may aid in improving psychological well-being. Further research is necessary before a clinical recommendation can be offered regarding use of mindfulness instruction to alleviate anxiety in men with low-grade prostate cancer being managed with active surveillance.

References

1.  Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016;66:7-–30.

2.  Chen RC, Rumble RB, Loblaw DA, et al. Active surveillance for the management of localized prostate cancer (Cancer Care Ontario Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol 2016;34:2182–90.

3.  Latini DM, Hart SL, Knight SJ, et al; CaPSURE Investigators. The relationship between anxiety and time to treatment for patients with prostate cancer on surveillance. J Urol 2007;178(3 Pt 1):826–31; discussion 831–2.

4.  Tan HJ, Marks LS, Hoyt MA, et al. The relationship between intolerance of uncertainty and anxiety in men on active surveillance for prostate cancer. J Urol 2016;195:1724–30.

References

1.  Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016;66:7-–30.

2.  Chen RC, Rumble RB, Loblaw DA, et al. Active surveillance for the management of localized prostate cancer (Cancer Care Ontario Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol 2016;34:2182–90.

3.  Latini DM, Hart SL, Knight SJ, et al; CaPSURE Investigators. The relationship between anxiety and time to treatment for patients with prostate cancer on surveillance. J Urol 2007;178(3 Pt 1):826–31; discussion 831–2.

4.  Tan HJ, Marks LS, Hoyt MA, et al. The relationship between intolerance of uncertainty and anxiety in men on active surveillance for prostate cancer. J Urol 2016;195:1724–30.

Issue
Journal of Clinical Outcomes Management - July 2016, VOL. 23, NO. 7
Issue
Journal of Clinical Outcomes Management - July 2016, VOL. 23, NO. 7
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Help for Active Surveillance Anxiety in Men with Prostate Cancer
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