This trial studies how well mindfulness education works in reducing surveillance stress in participants with prostate cancer and their spouses. Mindfulness education may help to reduce the effects of active surveillance stress, uncertainty, and rumination.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02871752.
PRIMARY OBJECTIVE:
I. Examine longitudinal change in positive and negative psychological responses to active surveillance (AS) between groups over time.
SECONDARY OBJECTIVE:
I. Observe the relation between positive and negative psychological responses to AS and AS adherence between groups over time.
TERTIARY OBJECTIVE:
I. Explore dyadic factors on positive and negative psychological responses to AS and AS adherence between groups over time.
OUTLINE: Participants are randomized into 1 of 2 groups.
Before starting the course intervention, participants complete a baseline assessment.
GROUP A: Participants attend mindfulness-based stress reduction (MBSR) courses over 9 weeks (1 hour orientation, 8 weekly 2.5 hour sessions, 1 4-hour retreat) and complete individual exercises for homework over 35 minutes 6 days per week. Participants also receive weekly eHealth email messages with information relevant to the course learning objectives.
GROUP B: Participants attend health promotion courses over 9 weeks (1 hour orientation, 8 weekly 2.5 hour sessions, 1 4-hour retreat) and complete individual exercises for homework over 35 minutes 6 days per week. Participants also receive weekly eHealth email messages with information relevant to the course learning objectives.
After completion of study, participants are followed up at 8 weeks, 6 months, and 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNorthwestern University
Principal InvestigatorDavid Victorson