Clinical trial · Interventional
Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
- 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 objective of the study is to develop and test the feasibility, acceptability, and initial efficacy of a novel couples-based behavioral weight and symptom management intervention for obese breast cancer survivors and their partners. The proposed project consists of two phases. Phase I will include intervention development and refinement. Intervention development will be guided by the research team's prior work, the interdependence model of communal coping and behavior change, and information obtained from couples participating in focus groups. The intervention protocol will then be tested with 5 couples to assist with refinement of intervention content. During phase II, the feasibility, acceptability and initial efficacy of the intervention will be examined. Obese breast cancer survivors in the three years following treatment and their overweight or obese partners will receive 6 weekly and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The intervention will be provided in a couples-based format where each couple will meet separately with the therapist. Couples will be assessed at pre-, post-, and 3-months post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e., insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer survivors and their partners. It is hypothesized that the intervention will be feasible (i.e., completed sessions), and participants will find the intervention acceptable as assessed by a measure of treatment acceptability. It is also hypothesized that participants will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity, and their change in weight will covary with change in symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that participants with greater weight loss will evidence improved functioning in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Couples-Based Behavioral Weight and Symptom Management | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Couples-Based Behavioral Weight and Symptom Management
- description
- Participants will receive 12 session (6 weekly and 6 biweekly) of a behavioral weight and symptom management intervention.
- interventionNames
- Behavioral: Couples-Based Behavioral Weight and Symptom Management
Primary outcomes (11)
- measure
- Change in Weight
- timeFrame
- baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
- description
- Participants will be weighed at each assessment and each session.
- measure
- Change in steps per day
- timeFrame
- Through study completion (an average of 31 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Phase I: Intervention Development and Refinement: Inclusion Criteria: * Patients: * Female, * obese (BMI \>30) * partnered * diagnosis of non-metastatic breast cancer (stages I-III) * completed adjuvant chemotherapy and/or radiation treatment in the last 5 years * healthy enough to participate in a home-based walking program (if participating in intervention refinement), * able to speak English * able and willing to give informed consent. * Partners: * Overweight/obese (BMI \>25) * cohabiting partner of a woman with non-metastatic breast cancer completing adjuvant chemotherapy and/or radiation in the last 5 years * healthy enough to participate in a home-based walking program (if participating in intervention refinement) * able to speak English * able and willing to give informed consent. Exclusion Criteria: for both patients and partners * male breast cancer survivors * non-ambulatory * unable to provide informed consent * have a major mental illness (i.e., schizophrenia); * have a mental illness that is not being treated/controlled (i.e., bipolar disorder) * reside \> 100 miles from the research site. Phase II: Feasibility, Acceptability, and Efficacy of the Intervention Inclusion Criteria: * Patients: * Female, obese (BMI \>30) * partnered * diagnosis of non-metastatic breast cancer (stages I-III) * completed adjuvant chemotherapy and/or radiation treatment in the last 3 years * healthy enough to participate in a home-based walking program * able to speak English * able and willing to give informed consent. * Partners: * Overweight/obese (BMI \>25) * cohabiting partner of a woman with non-metastatic breast cancer completing adjuvant chemotherapy and/or radiation in the three years * healthy enough to participate in a home-based walking program * able to speak English * able and willing to give informed consent. Exclusion Criteria: for both patients and partners * male breast cancer survivors * non-ambulatory * unable to provide informed consent * have a major mental illness (i.e., schizophrenia) * have a mental illness that is not being treated/controlled (i.e., bipolar disorder) * reside \> 100 miles from the research site. * Pregnant women will also be excluded from the study.
References
Publications (0)
Data not yet available