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

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ClinicalTrials.gov Identifier: NCT02871752
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : April 18, 2018
Sponsor:
Collaborators:
Fox Chase Cancer Center
University of Michigan
NorthShore University HealthSystem
University of Chicago
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Victorson, 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Health promotion Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education
Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MBSR (Mindfulness condition)
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.
Behavioral: Health promotion
mindfulness-based stress reduction

Active Comparator: HealthPro (Control Matched Condition)
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.
Behavioral: Health promotion
mindfulness-based stress reduction




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871752


Contacts
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Contact: David E Victorson, Ph.D. 847-467-3060 d-victorson@northwestern.edu
Contact: Bruriah E Horowitz, M.Ed. 312-503-3465 bruriah.horowitz@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Scott Eggener, M.D.    773-702-1860    seggener@surgery.bsd.uchicago.edu   
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Kristian Novakovic, M.D.    224-364-7104    KNovakovic@northshore.org   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Todd Morgan, M.D.    734-615-6662    tomorgan@med.umich.edu   
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Alexander Kutikov, M.D.    215-728-2468    Alexander.Kutikov@fccc.edu   
Sponsors and Collaborators
Northwestern University
Fox Chase Cancer Center
University of Michigan
NorthShore University HealthSystem
University of Chicago
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David E Victorson, Ph.D. Northwestern University

Publications of Results:
American Cancer Society, Cancer Facts and Figures 2013. American Cancer Society, 2013.
Kabat-Zinn, J., Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. 1990, New York: Dell Publishing.

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Responsible Party: David Victorson, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT02871752     History of Changes
Other Study ID Numbers: STU00105259
R01CA193331-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Victorson, Northwestern University:
prostate cancer
active surveillance
MBSR
couples
health promotion
quality of life
mindfulness

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases