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Completed

NCT Number: NCT02871752

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

health promotion

Behavioral

mindfulness-based stress reduction

Primary outcomes

  1. longitudinal change in psychological responses as assessed through online survey

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

    longitudinal change in psychological responses as assessed through online survey

Secondary outcomes

  1. relation between psychological responses to AS as assessed by online survey

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

    relation between psychological responses to AS as assessed by online survey

  2. dyadic factors on psychological responses as assessed by online survey

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

    dyadic factors on psychological responses as assessed by online survey

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Endeavor Health
  • Fox Chase Cancer Center
  • National Cancer Institute (NCI)
  • University of Michigan

Registry information

Acronym: REASSUREME

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2016
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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