Clinical trial NCT02871752: Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education
Official title: Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
active surveillance
MBSR
couples
health promotion
quality of life
mindfulness
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Fox Chase Cancer Center
name: University of Michigan
name: Endeavor Health
name: National Cancer Institute (NCI)
First posted: 2016-08-18
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: longitudinal change in psychological responses as assessed through online survey
timeFrame: Baseline, Week 8, Month 6, Month 12
Secondary outcomes:
measure: relation between psychological responses to AS as assessed by online survey
timeFrame: Baseline, Week 8, Month 6, Month 12
measure: dyadic factors on psychological responses as assessed by online survey
timeFrame: Baseline, Week 8, Month 6, Month 12
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Northwestern University
name: David E Victorson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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