This trial aims to evaluate the effect of couples-based stress reduction exercises on prostate cancer management with active surveillance. The main outcome to be investigated is the change in psychological responses assessed by an online survey. The trial is recruiting in Illinois, Michigan, and Pennsylvania, USA.
The details
Many men with low-risk prostate cancer benefit from active surveillance. Active surveillance of prostate cancer refers to actively monitoring tumor growth without actually administering treatment. Some men experience stress and anxiety during active surveillance due to fear of the cancer suddenly progressing rapidly without treatment. Stress reduction exercises can help manage psychological responses during active surveillance.
This study will examine the effectiveness of an 8-week couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance. Any changes in psychological responses will be compared between MBSR and a health promotion program. An online survey will assess psychological responses for up to 12 months.
Who are they looking for?
This study will recruit about 600 men with prostate cancer on active surveillance within the past 12 months and their partners. Participants must have an internet connection and be able to perform basic activities of daily living.
Participants should not have any serious psychiatric illness. Patients cannot take part in the trial if they are bedridden or have a physical debilitation preventing them from taking part.
How will it work
Participants will be randomly assigned to either undergo an 8-week couples-based mindfulness-based stress reduction (MBSR) or a health promotion program.
MBSR uses a group format to instruct participants in the practice of meditation and yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations. Lesson activities include mindful meditation (such as awareness of breathing, body scan, sitting, walking), yoga, and group discussion. Sessions are weekly, each lasting 2.5 hours, over an 8-week period. There will also be a half-day retreat between Week 6 and 7, as well as daily homework assignments.
The health promotion program will be run in parallel during the same time period. The program will teach and promote healthy behaviors, skills, and lifestyles. These will include: (1) health behavioral change readiness and self-assessment; (2) physical activity and movement; (3) diet for optimal health; (4) emotional wellness and coping with difficulties; (5) social engagement, relationships intimacy, and health; (6) managing bodily pain; (7) weight management and weight loss strategies; (8) health behavior maintenance over the long-term.
Any changes in psychological responses during active surveillance will be compared between MBSR and a health promotion program. An online survey will assess psychological responses for up to 12 months.
