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Couples-Based Mindfulness for Young Breast Cancer Survivors (C-MBSR)

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ClinicalTrials.gov Identifier: NCT02840344
Recruitment Status : Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
University of Missouri, St. Louis
University of Missouri, Kansas City
Information provided by (Responsible Party):
Ann Bettencourt, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Couples MBSR Behavioral: Individual MBSR Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Couples-Based Mindfulness for Young Breast Cancer Survivors
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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

Active Comparator: 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.

Behavioral: Individual MBSR
Only the young breast cancer survivor will participate in the weekly video sessions and activities.




Primary Outcome Measures :
  1. Change in couple functioning measured by the Measured by the Dyadic Adjustment Scale [ Time Frame: Baseline to 6 months ]
    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).

  2. Change in couple functioning measured by the Measured by the Autonomy and Relatedness Inventory [ Time Frame: Baseline to 6 months ]
    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).

  3. Change in couple functioning measured by the Sexual Interest and Satisfaction Scale [ Time Frame: Baseline to 6 months ]
    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).

  4. Change in couple functioning measured by the Interpersonal Mindfulness Scale [ Time Frame: Baseline to 6 months ]
    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).

  5. Perceived Partner Responsiveness [ Time Frame: Baseline to 8 weeks ]
    This scale will be measured each week for the 8 weeks of the intervention


Secondary Outcome Measures :
  1. Change in anxiety scores measured by PROMIS -- Anxiety [ Time Frame: Baseline to 6 months ]
    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).

  2. Change in depression scores measured by the PROMIS -- Depression [ Time Frame: Baseline to 6 months ]
    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).

  3. Change in fatigue scores measured by PROMIS -- Fatigue [ Time Frame: Baseline to 6 months ]
    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).

  4. Change in stress scores measured by the Perceived Stress Scale [ Time Frame: Baseline to 6 months ]
    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).

  5. Changes in physical functioning measured by the PROMIS - Physical Function [ Time Frame: Baseline to 6 months ]
    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).

  6. Changes in salivary cortisol biomarker to assess stress levels [ Time Frame: Baseline to 8 weeks ]
    Saliva will be analyzed for cortisol and summary scores will be calculated for each condition (no individual scores will be reported).

  7. Changes in trait mindfulness measured by Mindful Attention and Awareness Scale [ Time Frame: Baseline to 6 months ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840344


Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
University of Missouri-Columbia
University of Missouri, St. Louis
University of Missouri, Kansas City
Investigators
Principal Investigator: Ann Bettencourt, PhD University of Missouri-Columbia

Responsible Party: Ann Bettencourt, Dr. Ann Bettencourt, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02840344     History of Changes
Other Study ID Numbers: 2003808
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ann Bettencourt, University of Missouri-Columbia:
Couple Functioning
Stress Reduction

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases