Telehealth Weight Loss Program for Breast Cancer Survivors

NCT04855552 | Active Not Recruiting

• 2 other identifiers: UPCC 17120844762
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of Breast; Body Weight; Overweight and Obesity; Cancer Survivors

Keywords

Breast Cancer; Cancer Survivor; Body Mass Index; Telehealth; Breast Carcinoma; Overweight; Obese

Outcome Measures

Primary Outcomes (5)

• Determine feasibility and Acceptability Using the City of Hope Quality of Life Instrument - Breast Cancer Patient to Assess Changes in Quality of Life

  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

  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

  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

  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

  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 Outcomes (3)

• To measure changes from pre- to post-weight-loss intervention for 1) body mass.

  24 Months

• To measure changes from pre- to post-weight-loss intervention for 2) Qualitative Changes in Mammographic Breast Density

  24 Months

• To measure changes from pre- to post-weight-loss intervention for 2) Quantitative Changes in Mammographic Breast Density

  24 months

Study Arms (1)

Single-Arms Longitudinal Group

EXPERIMENTAL

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; Behavioral: Behavioral Weight-Loss Program Via Telehealth - Weight Measures; Behavioral: Validated Surveys of Patient-Reported Outcomes

Interventions

Validated Surveys of Patient-Reported Outcomes BEHAVIORAL

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

Single-Arms Longitudinal Group

Behavioral Weight-loss Program Via Telehealth BEHAVIORAL

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.

Single-Arms Longitudinal Group

Behavioral Weight-Loss Program Via Telehealth - Weight Measures BEHAVIORAL

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.

Single-Arms Longitudinal Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania (Hospital of the University of Pennsylvania)

Philadelphia, Pennsylvania, 19104, United States

Location

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MeSH Terms

Conditions

Breast Neoplasms; Body Weight; Overweight; Obesity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Julia C Tchou, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 12 patients (and possibly up to 20) (2 telehealth groups with at least 6 participants; 1 group leader per group)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of the Rena Rowan Breast Center, Director of Breast Cancer Immuno-Oncology Research, Professor of Clinical Surgery, and Principal Investigator

Model Details: Single-arm longitudinal group to examine patient-reported outcomes, body mass, and mammographic density changes pre-and post-intervention.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 22, 2021
• Study Start: July 19, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

US (1)