Prostate Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

400

Study ID:

NCT02871752

Recruitment Status:

Recruiting

Sponsor:

Northwestern University

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There are 4 Locations for this study

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Northwestern University
Chicago Illinois, 60611, United States
NorthShore University HealthSystem
Evanston Illinois, 60201, United States More Info
Kristian Novakovic, M.D.
Contact
224-364-7104
[email protected]
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Todd Morgan, M.D.
Contact
734-615-6662
[email protected]
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Alexander Kutikov, M.D.
Contact
215-728-2468
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

400

Study ID:

NCT02871752

Recruitment Status:

Recruiting

Sponsor:


Northwestern University

How clear is this clinincal trial information?

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