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

Northwestern University225 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

225

Conditions

Prostate Cancer

Interventions

Health promotionBEHAVIORAL

mindfulness-based stress reduction

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Northwestern University

Chicago, Illinois, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

longitudinal change in psychological responses as assessed through online survey

Time frame: Baseline, Week 8, Month 6, Month 12

Secondary Outcomes

relation between psychological responses to AS as assessed by online survey

Time frame: Baseline, Week 8, Month 6, Month 12

dyadic factors on psychological responses as assessed by online survey

Time frame: Baseline, Week 8, Month 6, Month 12

Data from ClinicalTrials.gov

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