Couples-Based Mindfulness for Young Breast Cancer Survivors

NCT ID: NCT02840344

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-07-16

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Couples MBSR

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.

Group Type: EXPERIMENTAL

Couples MBSR

Intervention Type: BEHAVIORAL

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

Individual MBSR

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.

Group Type: ACTIVE_COMPARATOR

Individual MBSR

Intervention Type: BEHAVIORAL

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

Interventions

Couples MBSR

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

Intervention Type: BEHAVIORAL

Individual MBSR

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri, St. Louis

OTHER

Sponsor Role: collaborator

University of Missouri, Kansas City

OTHER

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ann Bettencourt

Dr. Ann Bettencourt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Bettencourt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

Other Identifiers

2003808

Identifier Type: -

Identifier Source: org_study_id