Behavioral Weight & Symptom Management for Breast Cancer Survivors &

Status Completed

Clinical Trial 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 weight loss will evidence improved functioning in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02574507
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	N/A
Start date	October 2015
Completion date	December 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04681911` - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer	Phase 2
Completed	`NCT04890327` - Web-based Family History Tool	N/A
Terminated	`NCT04066790` - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer	Phase 2
Completed	`NCT03591848` - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility	N/A
Recruiting	`NCT03954197` - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients	N/A
Terminated	`NCT02202746` - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer	Phase 2
Active, not recruiting	`NCT01472094` - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn	`NCT06057636` - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study	N/A
Completed	`NCT06049446` - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting	`NCT05560334` - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations	Phase 2
Active, not recruiting	`NCT05501769` - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer	Phase 1
Recruiting	`NCT04631835` - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer	Phase 1
Completed	`NCT04307407` - Exercise in Breast Cancer Survivors	N/A
Recruiting	`NCT03544762` - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation	Phase 3
Terminated	`NCT02482389` - Study of Preoperative Boost Radiotherapy	N/A
Enrolling by invitation	`NCT00068003` - Harvesting Cells for Experimental Cancer Treatments
Completed	`NCT00226967` - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT06019325` - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms