Mindfulness Education in Reducing Active Surveillance Stress in Participants with Prostate Cancer and Their Spouses
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.
- Must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance) * While AS criteria for each program varies slightly, all programs use the following clinical and pathological criteria: ** Clinical stage T1c or T2a prostate cancer, verified by a participating urologist ** Diagnosis of prostate cancer made on a 12 core needle biopsy (if any of this information was unavailable prior to consent or on the diagnostic biopsy report, the eligibility was contingent on either urologist review of the diagnostic biopsy or the pathological data from the confirmation biopsy) ** Biopsy Gleason score =< 6 OR Gleason score 7 (3+4 ONLY), with =< 3 cores positive
- Must be able to read, write, speak and understand English
- Must be able to perform basic activities of daily living (as determined by referring study recruiter at intake)
- Must be cognitively intact and free of serious psychiatric illness (as determined by study recruiter at intake)
- Unable to provide consent
- Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
Locations & Contacts
Contact: David Victorson
Contact: Scott E. Eggener
Contact: Kristian Robert Novakovic
Contact: Todd M. Morgan
Contact: Alexander Kutikov
Trial Objectives and Outline
I. Examine longitudinal change in positive and negative psychological responses to active surveillance (AS) between groups over time.
I. Observe the relation between positive and negative psychological responses to AS and AS adherence between groups over time.
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 Health Promotion courses (Mindfulness Health Promotion) 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 (HealthPro) 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 Phase & Type
No phase specified
Secondary IDs NCI-2018-00889, STU00105259
Clinicaltrials.gov ID NCT02871752