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Completed

NCT Number: NCT02840344

Couples-Based Mindfulness for Young Breast Cancer Survivors

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Couples MBSR

Behavioral

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

Individual MBSR

Behavioral

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • University of Missouri, Kansas City
  • University of Missouri, St. Louis

Registry information

Acronym: C-MBSR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2016
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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