Clinical trial · Interventional
Mindfulness Based Couples Therapy
Mindfulness Based Couples Therapy for Breast Cancer Survivors: A Pilot Study
NCT02349217CI-TRIAL-00060526completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cortisol Tests | Procedure | — | UNRESOLVED |
| Interviews | Behavioral | — | UNRESOLVED |
| Mindfulness-Based Relationship Enhancement (MBRE) | Behavioral | — | UNRESOLVED |
| Neurocognitive Tests | Behavioral | — | UNRESOLVED |
| Pain Assessment | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Self-Help Materials | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mindfulness Based Stress Reduction Intervention (MBRE)
- description
- 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.
- interventionNames
- Behavioral: Mindfulness-Based Relationship Enhancement (MBRE)
- Behavioral: Pain Assessment
- Behavioral: Questionnaires
- Behavioral: Neurocognitive Tests
- Procedure: Cortisol Tests
- Behavioral: Interviews
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.