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NCT02574507 · ClinicalTrials.gov registry record · NA
Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT02574507 is a NA study that has completed, run by Duke University. The registered enrollment target is 52 participants.
The verdict
NCT02574507, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study Summary
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 weig
Interventions
- BEHAVIORAL Couples-Based Behavioral Weight and Symptom Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-10 |
| Est. Completion | 2018-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02574507
The ClinicalTrials.gov registry entry for NCT02574507 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Couples-Based Behavioral Weight and Symptom Management is the first listed.
NCT02574507 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02574507 about?
NCT02574507 is a clinical study titled "Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners". 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 includ...
What is the current status of trial NCT02574507?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2015-10. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02574507?
The interventions under investigation include: Couples-Based Behavioral Weight and Symptom Management (BEHAVIORAL).
Who is sponsoring clinical trial NCT02574507?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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