Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners

Breast Cancer Clinical Trial

Official title:

Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574507
• Other study ID #: Pro00063328
• Secondary ID: 1F32CA200091-01
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: May 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke Cancer Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Change in Fasting insulin	Fasting insulin will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.	baseline and 3 months post-treatment (approximately 30-32 weeks)
Secondary	Change in IL-6	The pro-inflammatory cytokine IL-6 will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.	baseline and 3 months post-treatment (approximately 30-32 weeks)
Secondary	Change in IL-8	The pro-inflammatory cytokine IL-8 will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.	baseline and 3 months post-treatment (approximately 30-32 weeks)
Secondary	Change in TNF-alpha	The pro-inflammatory cytokine TNF-alpha will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.	baseline and 3 months post-treatment (approximately 30-32 weeks)
Secondary	Change in Adiponectin	The anti-inflammatory cytokine adiponectin will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.	baseline and 3 months post-treatment (approximately 30-32 weeks)
Secondary	Change in Heart Rate	Heart rate will be assessed via the wireless activity trackers (Fitbit) worn by participants throughout the study.	Through study completion (an average of 31 weeks)
Secondary	Treatment Acceptability Questionnaire (TAQ)	The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable).	post-treatment (approximately 30-32 weeks)
Secondary	Change in Session attendance rate	Treatment feasibility will be assessed by measuring the session attendance rate for each participant and each day.	week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
Secondary	Change in Use of intervention strategies	Participants' use of intervention strategies will be assessed using a measure developed for components of the present study. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session in the past week or past month depending on the timing of the questionnaire. A scale ranging from 0 "not at all" to 5 "2 or more times a day" will be used.	week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
Secondary	Change in partner support for eating and exercise	Partner support for eating and exercise will be assessed using a modified version of the Social Support for Diet and Exercise questionnaires. Participants will be asked to provide information about the amount of encouragement and discouragement they have received from their partner over the last three months regarding healthy eating and exercise. Items are rated on a 5 point scale from 1 "none" to 5 "very often."	pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
Secondary	Change in Self-Efficacy for Weight	The Weight Efficacy Lifestyle Questionnaire is an 8-item measure of eating self-efficacy. Participants are asked to provide information about how certain they are that they can resist overeating in difficult situation (e.g., over the weekend, when tired, etc.). Response choices range from 0= "not at all confident" to 10= "very confident."	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)
Secondary	Change in self-efficacy for managing chronic disease	The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale that asks participants to rate their confidence in doing certain activities (e.g., keep emotional distress from interfering with the things you want to do) on a scale from 1= "not at all confident" to 10= "totally confident." The wording of items was slightly altered to better match the sample intended for the present study.	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)