Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners

May 5, 2020 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Weight
Time Frame: 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)
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
Time Frame: Through study completion (an average of 31 weeks)
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
Time Frame: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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
Time Frame: baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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)
Time Frame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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
Time Frame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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)
Time Frame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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
Time Frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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)
Time Frame: baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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
Time Frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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
Time Frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Fasting insulin
Time Frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
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)
Change in IL-6
Time Frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
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)
Change in IL-8
Time Frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
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)
Change in TNF-alpha
Time Frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
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)
Change in Adiponectin
Time Frame: baseline and 3 months post-treatment (approximately 30-32 weeks)
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)
Change in Heart Rate
Time Frame: Through study completion (an average of 31 weeks)
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)
Treatment Acceptability Questionnaire (TAQ)
Time Frame: post-treatment (approximately 30-32 weeks)
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)
Change in Session attendance rate
Time Frame: week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
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
Change in Use of intervention strategies
Time Frame: week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18
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
Change in partner support for eating and exercise
Time Frame: pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)
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)
Change in Self-Efficacy for Weight
Time Frame: 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)
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)
Change in self-efficacy for managing chronic disease
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caroline S Dorfman, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00063328
  • 1F32CA200091-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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