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

Prostate Cancer Clinical Trial

— REASSUREME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871752
• Other study ID #: STU00105259
• Secondary ID: R01CA193331-01A1
• Status: Completed
• Phase: N/A
• Start date: August 10, 2016
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Health promotion
mindfulness-based stress reduction

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Northwestern University	Chicago	Illinois
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Northwestern University	Fox Chase Cancer Center, National Cancer Institute (NCI), NorthShore University HealthSystem, University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	longitudinal change in psychological responses as assessed through online survey	longitudinal change in psychological responses as assessed through online survey	Baseline, Week 8, Month 6, Month 12
Secondary	relation between psychological responses to AS as assessed by online survey	relation between psychological responses to AS as assessed by online survey	Baseline, Week 8, Month 6, Month 12
Secondary	dyadic factors on psychological responses as assessed by online survey	dyadic factors on psychological responses as assessed by online survey	Baseline, Week 8, Month 6, Month 12