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

October 13, 2018 updated by: Ann Bettencourt, University of Missouri-Columbia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65201
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline to 6 months
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).
Baseline to 6 months
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).
Baseline to 6 months
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).
Baseline to 6 months
Perceived Partner Responsiveness
Time Frame: Baseline to 8 weeks
This scale will be measured each week for the 8 weeks of the intervention
Baseline to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline to 6 months
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).
Baseline to 6 months
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).
Baseline to 6 months
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).
Baseline to 6 months
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).
Baseline to 6 months
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).
Baseline to 8 weeks
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).
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Missouri, Kansas City
University of Missouri, St. Louis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann Bettencourt, PhD, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2003808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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