Overweight and Obesity Clinical Trial
— TWLOfficial title:
Pilot Telehealth Weight Loss Program for Breast Cancer Survivors
Verified date | August 2023 |
Source | Abramson Cancer Center at Penn Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | December 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania (Hospital of the University of Pennsylvania) | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine |
United States,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | To measure changes from pre- to post-weight-loss intervention for 1) body mass. | 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 | |
Secondary | To measure changes from pre- to post-weight-loss intervention for 2) Qualitative Changes in Mammographic Breast Density | 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 | |
Secondary | To measure changes from pre- to post-weight-loss intervention for 2) Quantitative Changes in Mammographic Breast Density | 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 |
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