Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    


Intervention name(s): Couples-Based Behavioral Weight and Symptom Management
Intervention type(s): Behavioral
Intervention description(s): 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 model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; weight management; couples; symptom management