Clinical trial NCT02574507: Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
Official title: Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
weight management
couples
symptom management
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-14
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Phase I: Intervention Development and Refinement:

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.

Exclusion Criteria: for both patients and partners

* 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

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 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: for both patients and partners

* 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.

Primary outcomes:
measure: Change in Weight
timeFrame: 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)
measure: Change in steps per day
timeFrame: Through study completion (an average of 31 weeks)
measure: Change in 6 minute walk ability score
timeFrame: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
measure: Change in 6 minute walk pain score
timeFrame: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
measure: Change in Stanford Leisure-Time Activity Categorical Item (L-Cat)
timeFrame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
measure: Change in Eating Behavior
timeFrame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
measure: Change in The Brief Pain Inventory (BPI)
timeFrame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
measure: Change in Promis Fatigue Scale
timeFrame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
measure: Change in Profile of Mood States (POMS)
timeFrame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
measure: Change in Physical Activity based on the International Physical Activity Questionnaire
timeFrame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
measure: Change in eating behavior using the Three Factor Eating Questionnaire
timeFrame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Secondary outcomes:
measure: Change in Fasting insulin
timeFrame: baseline and 3 months post-treatment (approximately 30-32 weeks)
measure: Change in IL-6
timeFrame: baseline and 3 months post-treatment (approximately 30-32 weeks)
measure: Change in IL-8
timeFrame: baseline and 3 months post-treatment (approximately 30-32 weeks)
measure: Change in TNF-alpha
timeFrame: baseline and 3 months post-treatment (approximately 30-32 weeks)
measure: Change in Adiponectin
timeFrame: baseline and 3 months post-treatment (approximately 30-32 weeks)
measure: Change in Heart Rate
timeFrame: Through study completion (an average of 31 weeks)
measure: Treatment Acceptability Questionnaire (TAQ)
timeFrame: post-treatment (approximately 30-32 weeks)
measure: Change in Session attendance rate
timeFrame: week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
measure: Change in Use of intervention strategies
timeFrame: week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
measure: Change in partner support for eating and exercise
timeFrame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
measure: Change in Self-Efficacy for Weight
timeFrame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18)
measure: Change in self-efficacy for managing chronic disease
timeFrame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Caroline S Dorfman, PhD
role: PRINCIPAL_INVESTIGATOR
References: