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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Northwestern University

Current Primary Outcome: longitudinal change in psychological responses as assessed through online survey [ Time Frame: Baseline, Week 8, Month 6, Month 12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: August 5, 2016
Date Started: December 2015
Date Completion: December 2020
Last Updated: August 17, 2016
Last Verified: August 2016