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Mindfulness Based Couples Therapy

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ClinicalTrials.gov Identifier: NCT02349217
Recruitment Status : Active, not recruiting
First Posted : January 28, 2015
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention on relationship satisfaction with quality of life and immune system function among breast cancer survivors and their partners.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: Mindfulness-Based Relationship Enhancement (MBRE) Behavioral: Self-Help Materials Behavioral: Pain Assessment Behavioral: Questionnaires Behavioral: Neurocognitive Tests Procedure: Cortisol Tests Behavioral: Interviews

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mindfulness Based Couples Therapy for Breast Cancer Survivors: A Pilot Study
Actual Study Start Date : January 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mindfulness Based Stress Reduction Intervention (MBRE)

Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts.

Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.

Behavioral: Mindfulness-Based Relationship Enhancement (MBRE)
Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts.
Behavioral: Pain Assessment
Pain assessment administered at baseline and at follow up visit. Pain assessment involves submerging hand in cold water.
Behavioral: Questionnaires
Questionnaires completed at baseline and at follow up visit. Questionnaires ask about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
Other Name: Surveys
Behavioral: Neurocognitive Tests
Neurocognitive tests administered at baseline and at follow up visit. Tests to check memory and thinking abilities.
Procedure: Cortisol Tests
Cortisol testing performed after baseline visit and at follow up visit. Participants asked to collect saliva samples for cortisol assays immediately, 30, 45, and 60 minutes after awakening (representing the cortisol awakening response) and at noon, 4 P.M. and 8 P.M.
Other Name: Saliva tests
Behavioral: Interviews
Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.
Active Comparator: Standard of Care

Participants receive self-help materials that have been previously developed by MD Anderson's Office of Public Education, the American Cancer Society, and the National Cancer Institute.

Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.

Behavioral: Self-Help Materials
Participants and partner receive self-help materials.
Behavioral: Pain Assessment
Pain assessment administered at baseline and at follow up visit. Pain assessment involves submerging hand in cold water.
Behavioral: Questionnaires
Questionnaires completed at baseline and at follow up visit. Questionnaires ask about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
Other Name: Surveys
Behavioral: Neurocognitive Tests
Neurocognitive tests administered at baseline and at follow up visit. Tests to check memory and thinking abilities.
Procedure: Cortisol Tests
Cortisol testing performed after baseline visit and at follow up visit. Participants asked to collect saliva samples for cortisol assays immediately, 30, 45, and 60 minutes after awakening (representing the cortisol awakening response) and at noon, 4 P.M. and 8 P.M.
Other Name: Saliva tests
Behavioral: Interviews
Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.


Outcome Measures

Primary Outcome Measures :
  1. Feasibility of Mindfulness Based Couples Therapy Intervention Among Breast Cancer Survivors and Their Partners (intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions) [ Time Frame: 12 weeks ]
    Feasibility endpoint is intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Stage 0-IIIA breast cancer survivors and their partner
  2. All the female breast cancer survivors will be at least two months from receiving cancer treatment (surgery, adjuvant therapy or radiation) and within three years from completing cancer treatment, except for tamoxifen/aromatase inhibitors.
  3. Are able to read and write in English
  4. Are able to pass the Physical Activity Readiness Questionnaire or participant provides a letter from their physician or nurse practitioner clearing them for study participation
  5. All couples co-habiting for at least 3 years with current partner who is willing to participate in study
  6. Are 21 years of age or older

Exclusion Criteria:

  1. Male breast cancer survivors;
  2. Participants with a diagnosis of diabetes, unless they are able to provide a letter from a physician who will continue to monitor the participant during the research study
  3. Anti-inflammatory medications (e.g. statins, cholesterol medication)
  4. Consume excessive amounts of alcohol (>30 drinks/week)
  5. Pregnant or thinking about becoming pregnant during the study period
  6. Lactating women
  7. Major medical conditions involving the immune system such as autoimmune and/or inflammatory diseases
  8. Pressure readings >/=140/90 mm Hg, as defined by the 7th Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, will be deemed ineligible to participate and excluded from the study. They will be referred to their family physician or community services. Those ineligible based on their initial blood pressure reading are allowed to participate if they provide a letter from a physician who will continue to monitor the participant during the research study.
  9. A hemoglobin level < 10g/dl
  10. Person less than 21 years of age
Contacts and Locations

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): NCT02349217


Locations
United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Cobi J. Heijnen, PHD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02349217     History of Changes
Other Study ID Numbers: 2014-0233
NCI-2015-00507 ( Registry Identifier: NCI CTRP )
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by M.D. Anderson Cancer Center:
Breast cancer
Breast cancer survivors
Breast cancer partners
Mindfulness-Based Relationship Enhancement
MBRE
Standard of care
Pain Assessment
Questionnaires
Surveys
Neurocognitive Tests
Cortisol Tests
Saliva tests
Interviews
Meditation
Yoga
Self-help materials

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents