Couples-Based Mindfulness for Young Breast Cancer Survivors

NCT02840344 | Completed

• 1 other identifier: 2003808
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Couple Functioning; Stress Reduction

Outcome Measures

Primary Outcomes (5)

• Change in couple functioning measured by the Measured by the Dyadic Adjustment Scale

  The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).

  Baseline to 6 months

• Change in couple functioning measured by the Measured by the Autonomy and Relatedness Inventory

  The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).

  Baseline to 6 months

• Change in couple functioning measured by the Sexual Interest and Satisfaction Scale

  The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).

  Baseline to 6 months

• Change in couple functioning measured by the Interpersonal Mindfulness Scale

  The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).

  Baseline to 6 months

• Perceived Partner Responsiveness

  This scale will be measured each week for the 8 weeks of the intervention

  Baseline to 8 weeks

Secondary Outcomes (7)

• Change in anxiety scores measured by PROMIS -- Anxiety

  Baseline to 6 months

• Change in depression scores measured by the PROMIS -- Depression

  Baseline to 6 months

• Change in fatigue scores measured by PROMIS -- Fatigue

  Baseline to 6 months

• Change in stress scores measured by the Perceived Stress Scale

  Baseline to 6 months

• Changes in physical functioning measured by the PROMIS - Physical Function

  Baseline to 6 months

Study Arms (2)

Couples MBSR

EXPERIMENTAL

Young breast cancer survivors and their partners take part in an 8-week Couples Mindfulness-Based Stress reduction (C-MBSR) intervention. The course will be taught through recorded videos of a trained MBSR instructor. The young breast cancer survivor and partner will be asked to watch a video module, together, each week for a total of 8 weeks. The C-MBSR course consists of practicing mindful stress reduction techniques and filling out handouts. Both members of the couple will be asked to complete surveys assessing primary and secondary outcome measures administered at baseline and after final session. Participants will be asked to provide a Salivary Cortisol sample at baseline and after the 8th session. Follow up Surveys will be administered at one and three months after intervention.

Behavioral: Couples MBSR

Individual MBSR

ACTIVE COMPARATOR

Young breast cancer survivors take part in an 8-week Individual Mindfulness-Based Stress reduction (I-MBSR) intervention. The course will be taught through recorded videos of a trained MBSR instructor. The young breast cancer survivor will be asked to watch a video module each week for 8 weeks in a row. The I-MBSR course consists of practicing mindful stress reduction techniques and filling out handouts. Both members of the couple will be asked to complete surveys assessing primary and secondary outcome measures administered at baseline and after final session. Participants will be asked to provide a Salivary Cortisol sample at baseline and after the 8th session. Follow up Surveys will be administered at one and three months after intervention.

Behavioral: Individual MBSR

Interventions

Couples MBSR BEHAVIORAL

Both members of the couple will be asked to participate in the weekly video sessions and activities.

Couples MBSR

Individual MBSR BEHAVIORAL

Only the young breast cancer survivor will participate in the weekly video sessions and activities.

Individual MBSR

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• University of Missouri, St. Louis: collaborator
• University of Missouri, Kansas City: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ann Bettencourt, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ann Bettencourt

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 21, 2016
• Study Start: October 1, 2017
• Primary Completion: July 16, 2018
• Study Completion: July 16, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)