Telehealth Weight Loss Program for Breast Cancer Survivors (TWL)

August 28, 2023 updated by: Julia Tchou, Abramson Cancer Center at Penn Medicine

Pilot Telehealth Weight Loss Program for Breast Cancer Survivors

This is a single-arm longitudinal group to examine patient-reported outcomes, body mass and mammographic density changes pre- and post- weight loss intervention of breast cancer survivors using video conferencing telehealth visits.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will receive weekly group sessions of lifestyle counseling for the first 20 weeks, followed by every other week sessions in weeks 22 and 24, for a total of 6 months of intervention. These group sessions, with 6 participants per group, will be delivered virtually via a HIPAA Compliant Teleconference Platform. The expected number of participants is at least 2 and no more than 6 in this 90-min group sessions which will be provided by a counselor from Penn Center for Weight and Eating Disorders.

The content of the sessions addresses the domains associated with behavioral weight management, including nutrition, exercise, stress and emotion management, and lifestyle modification strategies (to improve adherence to the diet and activity plan). Participants will monitor energy intake and physical activity daily to help them achieve recommended calorie and activity goals. Self-monitoring will be encouraged online with MyFitnessPal.com, which will be shared with the study staff to increase accountability and provide opportunity for feedback to participants.

Each participant will also be mailed a digital scale so they can weigh themselves each week and report their weight to the group leader. Participants will be encouraged to start with at least 10 minutes of moderately vigorous physical activity (e.g., brisk walking, swimming), at least five days per week, building up to at least 30 minutes per day (150 minutes per week) by week 6.

The primary objective is to assess feasibility and acceptance of telehealth weight loss intervention by the participants. The participants will be asked to complete the following surveys at two time points: baseline (pre-) and treatment end (at week 24). The participants will complete the following psychosocial measures.

  1. City of Hope Quality of Life (COH-QOL) Instrument - Breast Cancer Patient (QOL-BC)
  2. The International Physical Activity Questionnaire (IPAQ) Short Form - that assess the types and intensity of physical activity and sitting time in which people routinely engage. It provides an estimate of total physical activity in MET-min/week and time spent sitting.
  3. Patient Health Questionnaire (PHQ-9) (Depression)
  4. Acceptability of Intervention Measure

Finally, investigators will conduct an exit interview with each participant to assess the acceptability of the intervention, the delivery of the intervention via telehealth, and the patients' satisfaction with their treatment outcomes. Investigators will also solicit suggestions for improvements to the program for future interventions.

The secondary objectives are to measure changes from pre- to post weight-loss intervention for 1) body mass and 2) mammographic breast density.

To assess body mass changes, weight will be reported at baseline and after week 24 of the intervention. The scale will be mailed to participants at the beginning of the study. Participants' height from the electronic medical record will be used. Percent weight loss will be calculated to assess weight change across participants.

To assess mammographic breast density changes, investigators will measure mammographic density of annual mammogram pre- and post weight-loss program. Annual mammograms are routinely performed for breast cancer survivors except for those who have had bilateral mastectomy. Two annual mammograms will be used to measure mammographic density. The annual mammogram performed between 1 month - 12 months prior to weight loss program initiation will be used as baseline (pre-intervention). The post-intervention mammogram will be the first annual mammogram performed after weight loss program. If routine annual mammogram occurs during the 20-week weight loss program, then the next annual mammogram will be used for breast density assessment.

Therefore, study duration for each participant from enrollment to completion (mammographic density) is estimated to be up to 24 months.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • 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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania (Hospital of the University of Pennsylvania)

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of in situ or invasive breast cancer
  • Have completed breast cancer surgery, adjuvant cytotoxic chemotherapy (as indicated) and adjuvant radiation therapy (as indicated) at least 6-months prior to enrollment
  • Not on active treatment for other cancer for at least 6-months prior to enrollment
  • Currently cancer free
  • Overweight or obese (BMI of 25 kg/m^2 or greater)
  • Have internet access and videoconferencing capability

Exclusion Criteria:

  • Current use of weight loss medication (OTC or prescription) or participation in behavioral weight loss program
  • Currently participating in a behavioral weight loss program
  • Self-report of alcohol or substance abuse within the past 12-months, including at-risk drinking (current consumption of more than 14 drinks per week)
  • Undergone bilateral mastectomy
  • History of Bulimia nervosa
  • Inability to provide informed consent

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
Intervention / Treatment
Experimental: Single-Arms Longitudinal Group
Behavioral weight-loss program via telehealth (video conferencing). Participants will receive weekly group sessions of lifestyle counseling for the first 20-weeks, followed by every other week sessions in weeks 22 and 24, for a total of 6-months of intervention.
Behavioral: Behavioral Weight-loss Program Via Telehealth
Investigators will use a manual based on the DPP, as adapted previously for the endometrial cancer population and now adapted for breast cancer survivors. Dr.Courtney McCuen-Wurst, has extensive experience in working with persons with overweight and obesity with medical comorbidities. She also has experience leading group interventions at our Center via telehealth. The content of the sessions addresses the domains associated with behavioral weight management including nutrition, exercise, stress and emotion management, and lifestyle modification strategies (to improve adherence to the diet and activity plan). Participants will monitor energy intake and physical activity daily to help them achieve recommended calorie and activity goals. Self-monitoring will be encouraged online with MyFitnessPal.com, which will be shared with the study staff to increase accountability and provide opportunity for feedback to participants.
Behavioral: Behavioral Weight-Loss Program Via Telehealth - Weight Measures
Each participant will also be mailed a digital scale (Eat Smart) so they can weigh themselves each week and report their weight to the group leader; patients will be encouraged to take a picture of their weight on the scale after they step off (the number remains for 3-seconds) and send the picture to Dr. McCuen-Wurst. Participants will be encouraged to start with at least 1-minutes of moderately vigorous physical activity (e.g. brisk walking, swimming), at least five days per week, building up to at least 30-minutes per day (150-minutes per week) by week-6.
Behavioral: Validated Surveys of Patient-Reported Outcomes

The following surveys will be completed by participants pre- and post-intervention:

  • COH-QOL Instrument - Breast Cancer Patient (QOL-BC)
  • International Physical Activity Questionnaire (IPAQ) Short Form
  • Patient Health Questionnaire (PHQ-9) (Depression)
  • Acceptability of Intervention Measure

The following survey will be completed post-intervention

• Exit interview regarding acceptability of the program.

The following measurements/clinical tests results will be collected and compared pre- and post-intervention:

  • Anthropometric measurements: height (self-report); weight (as measured on scale provided by study)
  • Mammographic breast density estimated in annual clinical mammogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine feasibility and Acceptability Using the City of Hope Quality of Life Instrument - Breast Cancer Patient to Assess Changes in Quality of Life
Time Frame: 24 weeks

To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the City of Hope Quality of Life Instrument (COH-QOL) - Breast Cancer Patient (QOL-BC) at two time points: baseline (pre-) and treatment end (at week 24).

  • COH-QOL Instrument - Breast Cancer Patient (QOL-BC) - 46 items
  • The scoring is based on a scale of 0 = worst outcome to 10 = best outcome. Some items have reverse anchors and the value should be scored as the reverse of the item circled, e.g., if a patient selected "4" then their score on a reverse anchor would be 10 - 4 = 6.
24 weeks
Determine feasibility and Acceptability Using the International Physical Activity Questionnaire to Assess Changes in Physical Activity
Time Frame: 24 weeks

To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the International Physical Activity Questionnaire (IPAQ) at two time points: baseline (pre-) and treatment end (at week 24).

  • The International Physical Activity Questionnaire (IPAQ) Short Form
  • This is an open-ended questionnaire surrounding individuals' last 7-day recall of physical activity.
24 weeks
Determine feasibility and Acceptability Using the Patient Health Questionnaire to Assess Changes in Measures of Depression
Time Frame: 24 weeks

To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the Patient Health Questionnaire (PHQ-9) (Depression) at two time points: baseline (pre-) and treatment end (at week 24).

- The PHQ-9 is a nine item questionnaire and the scoring is based on a scale of 0= best outcome to 3 = worst outcome. Total scores range from 0 to 27 and higher scores are associated with higher severities of depression, ranging from minimal to severe.
24 weeks
Using the Acceptability of Intervention Measure to Assess Acceptability and Feasibility
Time Frame: 24 weeks

To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the Acceptability of Intervention Measure at two time points: baseline (pre-) and treatment end (at week 24).

- The Acceptability of Intervention Measure is a four item questionnaire and the scoring is based on a scale ranging from 1 = completely disagree to 5= Completely Agree. Higher scores are associated with greater acceptability of the intervention.
24 weeks
Requesting Direct Verbal Feedback From Participants to Assess Elements of the Program that Work Well, to Acquire Suggestions, and to Seek Suggestions to Determine Feasibility and Acceptability
Time Frame: 24 weeks
Finally, investigators will conduct an exit interview with each participant to assess the acceptability of the intervention, the delivery of the intervention via telehealth, and their satisfaction with their treatment outcomes. Investigators will also solicit suggestions for improvements to the program for future interventions.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure changes from pre- to post-weight-loss intervention for 1) body mass.
Time Frame: 24 Months
To assess change in body mass index (BMI), height (measured in meters) and weight (measured in kilograms) will be combined to report BMI in kg/m^2. Weight will be reported at baseline and after week 24 of the intervention. Participants' height (in meters) will be collected from the electronic medical record at baseline.
24 Months
To measure changes from pre- to post-weight-loss intervention for 2) Qualitative Changes in Mammographic Breast Density
Time Frame: 24 Months
To assess mammographic breast density changes, investigators will measure mammographic density of annual mammogram pre- and post-weight-loss program. The qualitative MBD as reported by Breast Imaging-Reporting and Data System (BI-RADS) scores are collected from the clinical radiologist reports.
24 Months
To measure changes from pre- to post-weight-loss intervention for 2) Quantitative Changes in Mammographic Breast Density
Time Frame: 24 months
To assess mammographic breast density changes, investigators will measure mammographic density of annual mammogram pre- and post-weight-loss program. Quantitative MBD will be analyzed using LIBRA, which is a fully-automated, free, and publicly available program that estimates MBD. Following digital segmentation, the LIBRA software analysis provides breast area, absolute dense area, and area percent density for each image of a mammographic study. Mean breast area (cm^2), mean dense area (cm^2), and quantitative MBD (%) will be calculated for each mammographic study as described.
24 months

Collaborators and Investigators

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

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Julia C Tchou, MD, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 19, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 17120
  • 844762 (Other Identifier: IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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