Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00507 | Registry Identifier | NCI CTRP-Clinical Trials Reporting Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Stress Reduction Intervention (MBRE) | Experimental | 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. |
|
| Standard of Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Relationship Enhancement (MBRE) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Feasibility endpoint is intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions. | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Dantzer, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson General Hospital | Houston | Texas | 77026 | United States | ||
| University of Texas MD Anderson Cancer Center |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D000073216 | Mental Status and Dementia Tests |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Self-Help Materials | Behavioral | Participants and partner receive self-help materials. |
|
| Pain Assessment | Behavioral | Pain assessment administered at baseline and at follow up visit. Pain assessment involves submerging hand in cold water. |
|
| Questionnaires | Behavioral | 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. |
|
|
| Neurocognitive Tests | Behavioral | Neurocognitive tests administered at baseline and at follow up visit. Tests to check memory and thinking abilities. |
|
| Cortisol Tests | Procedure | 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. |
|
|
| Interviews | Behavioral | Interviews conducted after follow up visit. These interviews are audio-taped and transcribed. |
|
| Houston |
| Texas |
| 77030 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |