Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Health promotion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR (Mindfulness condition)<br>MBSR (mindfulness-based stress reduction) is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha 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 the following: (1) mindful meditation (e.g., awareness of breathing, body scan, sitting, walking); (2) yoga; and (3) group discussion. | Behavioral: Health promotion<br>* mindfulness-based stress reduction<br>|
| Active Comparator: HealthPro (Control Matched Condition)<br>HealthPro is a health promotion program designed by Dr. David Victorson of Northwestern University Medical Social Sciences Department and his research team to function as a matched control for the MBSR intervention in this research study. The program teaches and promotes healthy behaviors, skills, and lifestyles. Major learning themes include: (1) health behavioral change readiness and self-assessment; (2) physical activity, movement, and non-sedentary lifestyles; (3) dietary and nutritional considerations 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. | Behavioral: Health promotion<br>* mindfulness-based stress reduction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| longitudinal change in psychological responses as assessed through online survey | longitudinal change in psychological responses as assessed through online survey | Baseline, Week 8, Month 6, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation between psychological responses to AS as assessed by online survey | relation between psychological responses to AS as assessed by online survey | Baseline, Week 8, Month 6, Month 12 | 
| dyadic factors on psychological responses as assessed by online survey | dyadic factors on psychological responses as assessed by online survey | Baseline, Week 8, Month 6, Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MBSR, prostate cancer, active surveillance, couples, health promotion, quality of life, mindfulness