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Mindfulness Based Couples Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02349217
Recruitment Status : Active, not recruiting
First Posted : January 28, 2015
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE January 23, 2015
First Posted Date  ICMJE January 28, 2015
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Based Couples Therapy
Official Title  ICMJE Mindfulness Based Couples Therapy for Breast Cancer Survivors: A Pilot Study
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.
Detailed Description

Baseline Visit:

If you are found to be eligible to take part in this research study, you will return to the clinic about a week later for the Baseline Visit. You will be instructed to fast (eat nothing and drink only water) for at least 8 hours before this visit.

  • Blood (about 4-5 tablespoons) will be drawn for tests of your immune function, stress hormone levels, and blood sugar levels. After this blood test, you will be given breakfast.
  • You will complete a pain assessment which involves you submerging your hand in cold water. Researchers will use your response to measure your pain tolerance.
  • You will have electrocardiograms (EKGs) to check your heart function. The sensors will be attached at the beginning of the visit and then removed before you leave. You will be attached to the machine for several hours, but you will be able to be disconnected to take bathroom breaks, if needed.
  • You will complete questionnaires 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.
  • You will complete a series of traditional neurocognitive tests (for example, tests to check your memory and thinking abilities). You will take these tests on the computer and with a pen and paper.
  • Your blood pressure will be measured multiple times throughout the visit.

Study Groups and Interventions:

After the Baseline visit, you will be assigned to one of 2 groups. If you are in Group 1, you and your partner will take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course designed to alleviate stress and other symptoms among couples. The MBRE course will consist of eight sessions taught by a professional Mindfulness instructor. The sessions will occur 1 time a week and last about 2½ hours each time. The MBRE course will consist of meditation and yoga techniques and handouts. The sessions will focus on teaching participants (all female breast cancer survivors and partners) the basics of Mindfulness Based Relationship Enhancement.

Attendance at these sessions and completion of daily homework assignments requiring up to 45 minutes per day are essential to the program.

If you are in Group 2, you will 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.

Post-Intervention Follow-Up Visit:

If you are in Group 1, you will have a post-intervention follow-up visit about 12 weeks after your Baseline visit (4 weeks after you finish your 8-week intervention sessions). If you are in Group 2, you will have a post-intervention follow-up visit about 8 weeks after the Baseline Visit. You will fast for 8 hours before a post-intervention follow-up visit.

  • Blood (about 4 to 5 tablespoons) will be drawn to check your immune function, stress hormone levels, and blood sugar. After the blood is drawn you will be given breakfast.
  • You will complete the cold water pain tolerance test.
  • You will have electrocardiograms (EKGs).
  • You will complete questionnaires 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.
  • You will complete a series of traditional neurocognitive tests.
  • Your blood pressure will be measured multiple times throughout the visit.

Cortisol Testing:

After the Baseline and Follow-up Visits, you will be asked to give samples to measure cortisol, a hormone related to stress. You will place a small cotton tube in your mouth for about 2 minutes, or until the swab is completely soaked with your saliva. After this, you will place the swab back in the tube, and freeze the sample. You will be given containers to hold the samples when you freeze them, as well as to mark which day and time each sample was collected. You will take these samples 7 times a day (right when you wake up; about 30, 45, and 60 minutes after waking; and then at noon, 4:00 p.m., and 8:00 p.m.). Researchers will use these samples to measure the changes in cortisol throughout the day. You will collect these samples for 2 days during the week, and 2 days on the weekend. After you complete 4 total days of collecting saliva samples after each visit, you will mail them back to MD Anderson in pre-paid envelopes.

Program Satisfaction Evaluations:

After the follow-up visits, the study staff will conduct individual interviews with a small group of participants. Interview questions will address participants' overall reactions to and satisfaction with the mind-body intervention, the impact they felt from social support, motivation, and their own ability for increasing physical activity and well-being. The study staff will also ask questions about both positive and negative effects of participating in the intervention. Interviews will be conducted by the PI or a trained research coordinator. All interviews will last no longer than 90 minutes and will be audio-taped using a digital recorder and transcribed. All audio files will be destroyed after they are transcribed.

This is an investigational study.

Up to 30 couples (60 participants) will take part in this research study. All will be enrolled at MD Anderson.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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: 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Behavioral: Mindfulness-Based Relationship Enhancement (MBRE)
    • Behavioral: Pain Assessment
    • Behavioral: Questionnaires
    • Behavioral: Neurocognitive Tests
    • Procedure: Cortisol Tests
    • Behavioral: Interviews
  • 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.

    Interventions:
    • Behavioral: Self-Help Materials
    • Behavioral: Pain Assessment
    • Behavioral: Questionnaires
    • Behavioral: Neurocognitive Tests
    • Procedure: Cortisol Tests
    • Behavioral: Interviews
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02349217
Other Study ID Numbers  ICMJE 2014-0233
NCI-2015-00507 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cobi J. Heijnen, PHD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP