Ignite Creation Date:
2024-05-06 @ 7:40 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02574507
Status:
COMPLETED
Last Update Posted:
2020-05-06
First Post:
2015-10-05
Brief Title:
Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 teams 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 ie pain fatigue distress eating behavior and physical activity Exploratory outcomes examine biomarkers ie 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 ie 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1F32CA200091-01 | NIH | None | httpsreporternihgovquickSearch1F32CA200091-01 |