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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Health promotion

• Registration Number: NCT02871752
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2016-08-05
• Study Start: 2016-08-10
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-18
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

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Exclusion Criteria

• Unable to provide consent
• Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBSR (Mindfulness condition)	Health promotion	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.
HealthPro (Control Matched Condition)	Health promotion	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States