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 : July 12, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | January 23, 2015 | ||||
First Posted Date ICMJE | January 28, 2015 | ||||
Last Update Posted Date | July 12, 2022 | ||||
Actual Study Start Date ICMJE | January 2015 | ||||
Estimated Primary Completion Date | January 31, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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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.
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.
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. |
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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 |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
24 | ||||
Original Estimated Enrollment ICMJE |
60 | ||||
Estimated Study Completion Date ICMJE | January 31, 2023 | ||||
Estimated Primary Completion Date | January 31, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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-Clinical Trials Reporting Registry ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | M.D. Anderson Cancer Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | July 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |