Couples-Based Mindfulness for Young Breast Cancer Survivors

Breast Cancer Clinical Trial

— C-MBSR  

Official title:

Couples-Based Mindfulness for Young Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840344
• Other study ID #: 2003808
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 16, 2018

Study information

• Verified date: October 2018
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 16, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Couples MBSR
Both members of the couple will be asked to participate in the weekly video sessions and activities.
• Individual MBSR
Only the young breast cancer survivor will participate in the weekly video sessions and activities.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Missouri-Columbia	University of Missouri, Kansas City, University of Missouri, St. Louis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Perceived Partner Responsiveness	This scale will be measured each week for the 8 weeks of the intervention	Baseline to 8 weeks
Secondary	Change in anxiety scores measured by PROMIS -- Anxiety	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
Secondary	Change in depression scores measured by the PROMIS -- Depression	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
Secondary	Change in fatigue scores measured by PROMIS -- Fatigue	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
Secondary	Change in stress scores measured by the Perceived Stress 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
Secondary	Changes in physical functioning measured by the PROMIS - Physical Function	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
Secondary	Changes in salivary cortisol biomarker to assess stress levels	Saliva will be analyzed for cortisol and summary scores will be calculated for each condition (no individual scores will be reported).	Baseline to 8 weeks
Secondary	Changes in trait mindfulness measured by Mindful Attention and Awareness 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