SUO 2017: The REASSURE ME Trial

Washington, DC (UroToday.com) While active surveillance (AS) for the management of low risk prostate cancer is becoming an increasingly adopted treatment paradigm, many men and their partners can face a host of psychosocial stressors related to this approach. As such, Dr. Herrel and colleagues presented their trial design for the REASSURE ME trial, supporting emotion regulation, positive health behaviors, and surveillance adherence for men with prostate cancer on active surveillance. Psychosocial stressors can negatively affect short and long term psychosocial adjustment and quality of life and contribute to withdrawal from AS prematurely to seek definitive therapies such as surgery. The objective of this trial is to use a multi-site approach to examine the efficacy of mindfulness training compared with a time/attention−matched health promotion control among a large sample of men on AS and their spouses.

Trial design: 120 men on AS and their spouses will be examined with regards to their psychological response and adherence to AS when individuals participate in instructor-led mindfulness training (mindfulness−based stress reduction [MBSR]) over 12 months. This group will be compared with a health promotion control course (n=120 men on AS plus spouses). The trial utilizes a randomized, placebo−controlled, partially double−blinded study design over a four-year enrollment period. Each course consists of weekly, in-person, instructor led sessions devoted to mindful awareness practices or general health promotion practices over 8 weeks. Baseline measures (e.g., anxiety, fear of progression, quality of life) were obtained just prior to randomization, followed by repeated assessments at 2, 6, and 12 months. Enrollment is ongoing at all four sites, with a total enrollment in the first year of 57 men with newly diagnosed prostate cancer enrolling on AS and 27 spouses across three cities and four academic medical centers. Randomization of participants over the first year resulted in completion of three health promotion control courses and one mindfulness course. No adverse events were noted during these courses.

Thus far, the authors have demonstrated feasibility of enrollment, randomization, initial survey participation and compliance with course attendance. This work has the potential to offer men and their partners facing the stressors of AS with specialized emotional, cognitive, and physiological self-regulatory skills to cope more effectively and possibly prolong adherence to medically-warranted AS protocols.

Presented by: Lindsey Allison Herrel, MD, MS¹

Co-Authors: Todd Morgan MD¹, Bruriah Gutierrez MA², Carly Maletich MA², Stepahine Schuette BA², Alexander Kutikov MD³, Shilajit Kundu MD², Scott Eggener MD⁴, Charles Brendler MD⁵ and David Victorson PhD²

Affiliations: ¹University of Michigan, Ann Arbor, MI; ²Northwestern University, Chicago, IL; ³Fox Chase Cancer Center, Philadelphia, PA; ⁴University of Chicago, Chicago, IL; ⁵NorthShore University Health System, Chicago, IL

Written by: Zachary Klaassen, MD, Society of Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre @zklaassen_md at the 18th Annual Meeting of the Society of Urologic Oncology, November 20-December 1, 2017 – Washington, DC

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