Prostate Cancer
Conditions
Keywords
prostate cancer, active surveillance, MBSR, couples, health promotion, quality of life, mindfulness
Brief summary
We propose to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a sample of men on AS and their spouses.
Detailed description
The current study proposes to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a larger, more geographically representative sample of men on AS and their spouses. We will compare the MBSR intervention condition (Group A) with a health promotion and wellness condition (Group B) in a sample of prostate cancer patients and their spouses. We will evaluate its efficacy on self-reported measures of positive and negative psychological responses to AS. PRIMARY AIM Examine longitudinal change in positive and negative psychological responses to AS between groups over time. SECONDARY AIM Observe the relation between positive and negative psychological responses to AS and AS adherence between groups over time. THIRD AIM Explore dyadic factors on positive and negative psychological responses to AS and AS adherence between groups over time.
Interventions
BEHAVIORALHealth promotion
mindfulness-based stress reduction
Sponsors
Fox Chase Cancer Center
University of Michigan
Endeavor Health
National Cancer Institute (NCI)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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) * Must be at least 18 years of age * Must be able to read, write, speak and understand English * Must be able to perform basic activities of daily living (as determined by referring physician) * Must be cognitively intact and free of serious psychiatric illness (as determined by referring physician) * Must have access to the internet and ability to locate the assessment URL and/or ability to use a touchscreen keypad on a tablet device * Must be willing to commit to the 8-week MBSR or Health Promotion course, which includes attending weekly, 2.5 hours classes over an 8 week period, a half-day retreat between week 6 and 7 , and daily homework assignments * Must be willing to complete study assessments
Exclusion criteria
* Unable to provide consent * Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| longitudinal change in psychological responses as assessed through online survey | Baseline, Week 8, Month 6, Month 12 | longitudinal change in psychological responses as assessed through online survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| relation between psychological responses to AS as assessed by online survey | Baseline, Week 8, Month 6, Month 12 | relation between psychological responses to AS as assessed by online survey |
| dyadic factors on psychological responses as assessed by online survey | Baseline, Week 8, Month 6, Month 12 | dyadic factors on psychological responses as assessed by online survey |
Countries
United States
Outcome results
None listed