Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners

NCT ID: NCT02574507

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-12-31

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 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

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Couples-Based Behavioral Weight and Symptom Management

Participants will receive 12 session (6 weekly and 6 biweekly) of a behavioral weight and symptom management intervention.

Group Type: EXPERIMENTAL

Couples-Based Behavioral Weight and Symptom Management

Intervention Type: BEHAVIORAL

Investigators anticipate that the intervention developed in phase I will consist of a total of 12 sessions 90 minutes in length (18 therapy hours) spaced across approximately 5 months. Sessions are spaced to provide participants sufficient time to complete home practice exercises and adequately examine change in weight and maintenance of weight loss. Sessions will be conducted individually for each day. The first 6 sessions will occur weekly and the final 6 sessions will occur biweekly.

Interventions

Couples-Based Behavioral Weight and Symptom Management

Investigators anticipate that the intervention developed in phase I will consist of a total of 12 sessions 90 minutes in length (18 therapy hours) spaced across approximately 5 months. Sessions are spaced to provide participants sufficient time to complete home practice exercises and adequately examine change in weight and maintenance of weight loss. Sessions will be conducted individually for each day. The first 6 sessions will occur weekly and the final 6 sessions will occur biweekly.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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

• 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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline S Dorfman, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Cancer Institute

Durham, North Carolina, United States

Countries

United States

Other Identifiers

1F32CA200091-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00063328

Identifier Type: -

Identifier Source: org_study_id