Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02574507
- Run by
- Duke University
- People needed
- 52
- Starts
- 2015-10-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2020-05-06
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
Where it is running
- Duke Cancer Institute — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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