Clinical trial NCT02840344: Couples-Based Mindfulness for Young Breast Cancer Survivors
Official title: Couples-Based Mindfulness for Young Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Couple Functioning
Stress Reduction
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Missouri, St. Louis
name: University of Missouri, Kansas City
First posted: 2016-07-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to improve relationship, psychological, and physical adjustment among young breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet the specific needs for young breast cancer survivors and their partners. The intervention will be administered in your home by using recorded videos of a trained MBSR instructor. Before, during, and after the 8-week intervention, participants will be asked to complete surveys.

Detailed description: Participants will be young breast cancer survivors (YBCS) and their partners. Young breast cancer survivors are those diagnosed at age 45 or younger. This study includes stress reducing interventions known to have a positive influence on physical and psychological functioning that will be administered through recorded videos. The interventions include watching an hour-long video stress-reduction class, each week, for 8 weeks and practicing guided meditations. YBCS participants will be randomly assigned to either an 8-week mindfulness-based stress reduction course designed for couples (C-MBSR) or an 8-week mindfulness-based stress reduction course for individuals. At the end of the study all participants (regardless of what assignment) will receive both sets of stress-reducing videos. Partners of the YBCS assigned to the couples condition will also be asked to watch the 8 C-MBSR videos. Some young breast cancer survivor participants and their partners will be asked to complete provide salivary cortisol and all survivors and partners will be asked to complete the 4 surveys.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years to 45 years old when diagnosed with breast cancer
2. Diagnosed with stage 0, I, II, III breast cancer
3. within 1 to 6 years after diagnosis of breast cancer
4. Married or unmarried and living together.
5. Living anywhere in the United States
6. Both members of the couple must understand, read, and speak English
7. Both members of the couple must have regular access to email and willingness to use the Internet.

Exclusion Criteria:

1. Neither members of the couple may be experienced meditators (20 minutes daily, 5 days a week or more, for over a year) or graduates of a former MBSR class.

Primary outcomes:
measure: Change in couple functioning measured by the Measured by the Dyadic Adjustment Scale
timeFrame: Baseline to 6 months
measure: Change in couple functioning measured by the Measured by the Autonomy and Relatedness Inventory
timeFrame: Baseline to 6 months
measure: Change in couple functioning measured by the Sexual Interest and Satisfaction Scale
timeFrame: Baseline to 6 months
measure: Change in couple functioning measured by the Interpersonal Mindfulness Scale
timeFrame: Baseline to 6 months
measure: Perceived Partner Responsiveness
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change in anxiety scores measured by PROMIS -- Anxiety
timeFrame: Baseline to 6 months
measure: Change in depression scores measured by the PROMIS -- Depression
timeFrame: Baseline to 6 months
measure: Change in fatigue scores measured by PROMIS -- Fatigue
timeFrame: Baseline to 6 months
measure: Change in stress scores measured by the Perceived Stress Scale
timeFrame: Baseline to 6 months
measure: Changes in physical functioning measured by the PROMIS - Physical Function
timeFrame: Baseline to 6 months
measure: Changes in salivary cortisol biomarker to assess stress levels
timeFrame: Baseline to 8 weeks
measure: Changes in trait mindfulness measured by Mindful Attention and Awareness Scale
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Ann Bettencourt, PhD
role: PRINCIPAL_INVESTIGATOR
References: