Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners

NCT02574507 | Completed DMC

• 2 other identifiers: Pro000633281F32CA200091-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; weight management; couples; symptom management

Outcome Measures

Primary Outcomes (11)

• Change in Weight

  Participants will be weighed at each assessment and each session.

  baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

• Change in steps per day

  Participants will wear wireless activity trackers (Fitbits) to measure daily activity (e.g., steps taken). Participants will be provided with the activity trackers by study staff and begin to use the trackers following the pre-treatment assessment. Participants will continue to use the trackers throughout treatment. Participants will return the Fitbits to the study staff upon completion of the study.

  Through study completion (an average of 31 weeks)

• Change in 6 minute walk ability score

  The 6-minute walk test is a self-paced, timed test of the total distance in meters that a patient is able to walk over a six-minute period and assesses the ability to exert effort during activity.

  baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

• Change in 6 minute walk pain score

  The degree of pain experienced during the 6-minute walk test will also be assessed.

  baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

• Change in Stanford Leisure-Time Activity Categorical Item (L-Cat)

  The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active.

  baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

• Change in Eating Behavior

  Participants will also be asked to complete the Dietary Instrument for Nutrition Education (DINE). The DINE is a brief assessment of the amount of fat and dietary fiber in an individual's usual diet. Participants are provided with a list of food items and asked about the frequency with which they have eaten the items per week when considering the last month.

  baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

• Change in The Brief Pain Inventory (BPI)

  The BPI is a 9-item self-report measure assessing pain severity. Participants rate their pain on a scale from 0 to 10 where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Participants also rate their level of interference from pain.

  baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

• Change in Promis Fatigue Scale

  The Promis Fatigue Scale is a 6-item self-report measure of fatigue in the last week

  pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

• Change in Profile of Mood States (POMS)

  The POMS will be used to assess psychological distress. Each item is rated on a scale from 0 (not at all) to 4 (extremely) as being self-descriptive for the last seven days.

  baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

• Change in Physical Activity based on the International Physical Activity Questionnaire

  Participants will also complete the International Physical Activity Questionnaire (IPAQ). This seven-item questionnaire assesses the amount of time participants have spent doing moderate and vigorous physical activities in the last seven days.

  pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

• Change in eating behavior using the Three Factor Eating Questionnaire

  Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating.

  pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)

Secondary Outcomes (12)

• Change in Fasting insulin

  baseline and 3 months post-treatment (approximately 30-32 weeks)

• Change in IL-6

  baseline and 3 months post-treatment (approximately 30-32 weeks)

• Change in IL-8

  baseline and 3 months post-treatment (approximately 30-32 weeks)

• Change in TNF-alpha

  baseline and 3 months post-treatment (approximately 30-32 weeks)

• Change in Adiponectin

  baseline and 3 months post-treatment (approximately 30-32 weeks)

Study Arms (1)

Couples-Based Behavioral Weight and Symptom Management

EXPERIMENTAL

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

Behavioral: Couples-Based Behavioral Weight and Symptom Management

Interventions

Couples-Based Behavioral Weight and Symptom Management 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.

Couples-Based Behavioral Weight and Symptom Management

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Caroline S Dorfman, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 14, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

US (1)