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

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02871752

Collaborator

Fox Chase Cancer Center (Other), University of Michigan (Other), NorthShore University HealthSystem (Other), National Cancer Institute (NCI) (NIH)

400

Enrollment

Locations

Arms

75.7

Anticipated Duration (Months)

100

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 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

Actual Study Start Date :

Aug 10, 2016

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

longitudinal change in psychological responses as assessed through online survey [Baseline, Week 8, Month 6, Month 12]
longitudinal change in psychological responses as assessed through online survey

Secondary Outcome Measures

relation between psychological responses to AS as assessed by online survey [Baseline, Week 8, Month 6, Month 12]
relation between psychological responses to AS as assessed by online survey
dyadic factors on psychological responses as assessed by online survey [Baseline, Week 8, Month 6, Month 12]
dyadic factors on psychological responses as assessed by online survey

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611
2	NorthShore University HealthSystem	Evanston	Illinois	United States	60201
3	University of Michigan	Ann Arbor	Michigan	United States	48109
4	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111