Cancer SurvivorsTWLNCT04855552
Telehealth Weight Loss Program for Breast Cancer Survivors
A study testing Behavioral Weight-loss Program Via Telehealth, Behavioral Weight-Loss Program Via Telehealth - Weight Measures and Validated Surveys of Patient-Reported Outcomes in people with Cancer Survivors and Cancer of Breast, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer Survivors, Cancer of Breast, Body Weight
- What is being tested?
- Behavioral Weight-loss Program Via Telehealth, Behavioral Weight-Loss Program Via Telehealth - Weight Measures and Validated Surveys of Patient-Reported Outcomes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania (Hospital of the University of Pennsylvania)
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- City of Hope Quality of Life (COH-QOL) Instrument - Breast Cancer Patient (QOL-BC)
- 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.
- Patient Health Questionnaire (PHQ-9) (Depression)
- 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.
- Being tested
- Behavioral Weight-loss Program Via Telehealth, Behavioral Weight-Loss Program Via Telehealth - Weight Measures, Validated Surveys of Patient-Reported Outcomes
- Keywords
- Breast Cancer, Cancer Survivor, Body Mass Index, Telehealth, Breast Carcinoma, Overweight, Obese
- Medical subject headings
- Breast Neoplasms, Body Weight, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight-loss Program Via TelehealthBehavioural
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 Weight-Loss Program Via Telehealth - Weight MeasuresBehavioural
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.
Validated Surveys of Patient-Reported OutcomesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Weight-loss Program Via Telehealth; Behavioral: Behavioral Weight-Loss Program Via Telehealth - Weight Measures; Behavioral: Validated Surveys of Patient-Reported Outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: 24 Months
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.
Measured: 24 Months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start19 Jul 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm longitudinal group to examine patient-reported outcomes, body mass, and mammographic density changes pre-and post-intervention.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Tchou, Abramson Cancer Center at Penn Medicine
- Investigators
- Julia C Tchou, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855552
- Sponsor's protocol ID
- UPCC 17120
- Other IDs
- 844762
- Acronym
- TWL
- Status last verified
- Aug 2026
- First submitted
- 8 Apr 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goodwin PJ, Segal RJ, Vallis M, Ligibel JA, Pond GR, Robidoux A, Findlay B, Gralow JR, Mukherjee SD, Levine M, Pritchard KI. The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer. NPJ Breast Cancer. 2020 Feb 21;6:6. doi: 10.1038/s41523-020-0149-z. eCollection 2020.
PubMed 32133391Ligibel JA, Barry WT, Alfano C, Hershman DL, Irwin M, Neuhouser M, Thomson CA, Delahanty L, Frank E, Spears P, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hahn O, Hudis C, Winer EP, Wadden TA, Goodwin PJ. Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design. NPJ Breast Cancer. 2017 Sep 21;3:37. doi: 10.1038/s41523-017-0040-8. eCollection 2017.
PubMed 28948213Krouse RS, Grant M, McCorkle R, Wendel CS, Cobb MD, Tallman NJ, Ercolano E, Sun V, Hibbard JH, Hornbrook MC. A chronic care ostomy self-management program for cancer survivors. Psychooncology. 2016 May;25(5):574-81. doi: 10.1002/pon.4078. Epub 2016 Jan 25.
PubMed 26804708Williams AD, So A, Synnestvedt M, Tewksbury CM, Kontos D, Hsiehm MK, Pantalone L, Conant EF, Schnall M, Dumon K, Williams N, Tchou J. Mammographic breast density decreases after bariatric surgery. Breast Cancer Res Treat. 2017 Oct;165(3):565-572. doi: 10.1007/s10549-017-4361-y. Epub 2017 Jun 28.
PubMed 28660430Eliassen AH, Colditz GA, Rosner B, Willett WC, Hankinson SE. Adult weight change and risk of postmenopausal breast cancer. JAMA. 2006 Jul 12;296(2):193-201. doi: 10.1001/jama.296.2.193.
PubMed 16835425Parker ED, Folsom AR. Intentional weight loss and incidence of obesity-related cancers: the Iowa Women's Health Study. Int J Obes Relat Metab Disord. 2003 Dec;27(12):1447-52. doi: 10.1038/sj.ijo.0802437.
PubMed 14634673Birks S, Peeters A, Backholer K, O'Brien P, Brown W. A systematic review of the impact of weight loss on cancer incidence and mortality. Obes Rev. 2012 Oct;13(10):868-91. doi: 10.1111/j.1467-789X.2012.01010.x. Epub 2012 Jun 4.
PubMed 22672203Howell A, Anderson AS, Clarke RB, Duffy SW, Evans DG, Garcia-Closas M, Gescher AJ, Key TJ, Saxton JM, Harvie MN. Risk determination and prevention of breast cancer. Breast Cancer Res. 2014 Sep 28;16(5):446. doi: 10.1186/s13058-014-0446-2.
PubMed 25467785Hardefeldt PJ, Penninkilampi R, Edirimanne S, Eslick GD. Physical Activity and Weight Loss Reduce the Risk of Breast Cancer: A Meta-analysis of 139 Prospective and Retrospective Studies. Clin Breast Cancer. 2018 Aug;18(4):e601-e612. doi: 10.1016/j.clbc.2017.10.010. Epub 2017 Oct 17.
PubMed 29223719van den Brandt PA, Schulpen M. Mediterranean diet adherence and risk of postmenopausal breast cancer: results of a cohort study and meta-analysis. Int J Cancer. 2017 May 15;140(10):2220-2231. doi: 10.1002/ijc.30654. Epub 2017 Mar 5.
PubMed 28260236Christou NV, Lieberman M, Sampalis F, Sampalis JS. Bariatric surgery reduces cancer risk in morbidly obese patients. Surg Obes Relat Dis. 2008 Nov-Dec;4(6):691-5. doi: 10.1016/j.soard.2008.08.025. Epub 2008 Sep 20.
PubMed 19026373Adams TD, Stroup AM, Gress RE, Adams KF, Calle EE, Smith SC, Halverson RC, Simper SC, Hopkins PN, Hunt SC. Cancer incidence and mortality after gastric bypass surgery. Obesity (Silver Spring). 2009 Apr;17(4):796-802. doi: 10.1038/oby.2008.610. Epub 2009 Jan 15.
PubMed 19148123Sjostrom L, Gummesson A, Sjostrom CD, Narbro K, Peltonen M, Wedel H, Bengtsson C, Bouchard C, Carlsson B, Dahlgren S, Jacobson P, Karason K, Karlsson J, Larsson B, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on cancer incidence in obese patients in Sweden (Swedish Obese Subjects Study): a prospective, controlled intervention trial. Lancet Oncol. 2009 Jul;10(7):653-62. doi: 10.1016/S1470-2045(09)70159-7. Epub 2009 Jun 24.
PubMed 19556163Ursin G, Quershi SA. Mammographic density - a useful biomarker for breast cancer risk in epidemiologic studies. Norsk Epidemiologi. 2009, 10: 59-68.
Casagrande DS, Rosa DD, Umpierre D, Sarmento RA, Rodrigues CG, Schaan BD. Incidence of cancer following bariatric surgery: systematic review and meta-analysis. Obes Surg. 2014 Sep;24(9):1499-509. doi: 10.1007/s11695-014-1276-0.
PubMed 24817500
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Telehealth Weight Loss Program for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04855552
- Acronym / sponsor ID
- TWL / UPCC 17120
- Keywords
- Breast Cancer, Cancer Survivor, Body Mass Index, Telehealth, Breast Carcinoma, Overweight, Obese
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- City of Hope Quality of Life (COH-QOL) Instrument - Breast Cancer Patient (QOL-BC)
- 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.
- Patient Health Questionnaire (PHQ-9) (Depression)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm longitudinal group to examine patient-reported outcomes, body mass, and mammographic density changes pre-and post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Single-Arms Longitudinal Group | Experimental | Behavioral: Behavioral Weight-loss Program Via Telehealth, Behavioral: Behavioral Weight-Loss Program Via Telehealth - Weight Measures, Behavioral: Validated Surveys of Patient-Reported OutcomesBehavioral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Weight-loss Program Via TelehealthInvestigators 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. | Behavioural | Single-Arms Longitudinal Group |
| Behavioral Weight-Loss Program Via Telehealth - Weight MeasuresEach 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. | Behavioural | Single-Arms Longitudinal Group |
| Validated Surveys of Patient-Reported OutcomesThe 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 | Behavioural | Single-Arms Longitudinal Group |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
To measure changes from pre- to post-weight-loss intervention for 1) body mass.
Time frame: 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 measure changes from pre- to post-weight-loss intervention for 2) Quantitative Changes in Mammographic Breast Density
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 32133391Goodwin PJ, Segal RJ, Vallis M, Ligibel JA, Pond GR, Robidoux A, Findlay B, Gralow JR, Mukherjee SD, Levine M, Pritchard KI. The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer. NPJ Breast Cancer. 2020 Feb 21;6:6. doi: 10.1038/s41523-020-0149-z. eCollection 2020.
- Background: PubMed 28948213Ligibel JA, Barry WT, Alfano C, Hershman DL, Irwin M, Neuhouser M, Thomson CA, Delahanty L, Frank E, Spears P, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hahn O, Hudis C, Winer EP, Wadden TA, Goodwin PJ. Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design. NPJ Breast Cancer. 2017 Sep 21;3:37. doi: 10.1038/s41523-017-0040-8. eCollection 2017.
- Background: PubMed 26804708Krouse RS, Grant M, McCorkle R, Wendel CS, Cobb MD, Tallman NJ, Ercolano E, Sun V, Hibbard JH, Hornbrook MC. A chronic care ostomy self-management program for cancer survivors. Psychooncology. 2016 May;25(5):574-81. doi: 10.1002/pon.4078. Epub 2016 Jan 25.
- Background: PubMed 28660430Williams AD, So A, Synnestvedt M, Tewksbury CM, Kontos D, Hsiehm MK, Pantalone L, Conant EF, Schnall M, Dumon K, Williams N, Tchou J. Mammographic breast density decreases after bariatric surgery. Breast Cancer Res Treat. 2017 Oct;165(3):565-572. doi: 10.1007/s10549-017-4361-y. Epub 2017 Jun 28.
- Background: PubMed 16835425Eliassen AH, Colditz GA, Rosner B, Willett WC, Hankinson SE. Adult weight change and risk of postmenopausal breast cancer. JAMA. 2006 Jul 12;296(2):193-201. doi: 10.1001/jama.296.2.193.
- Background: PubMed 14634673Parker ED, Folsom AR. Intentional weight loss and incidence of obesity-related cancers: the Iowa Women's Health Study. Int J Obes Relat Metab Disord. 2003 Dec;27(12):1447-52. doi: 10.1038/sj.ijo.0802437.
- Background: PubMed 22672203Birks S, Peeters A, Backholer K, O'Brien P, Brown W. A systematic review of the impact of weight loss on cancer incidence and mortality. Obes Rev. 2012 Oct;13(10):868-91. doi: 10.1111/j.1467-789X.2012.01010.x. Epub 2012 Jun 4.
- Background: PubMed 25467785Howell A, Anderson AS, Clarke RB, Duffy SW, Evans DG, Garcia-Closas M, Gescher AJ, Key TJ, Saxton JM, Harvie MN. Risk determination and prevention of breast cancer. Breast Cancer Res. 2014 Sep 28;16(5):446. doi: 10.1186/s13058-014-0446-2.
- Background: PubMed 29223719Hardefeldt PJ, Penninkilampi R, Edirimanne S, Eslick GD. Physical Activity and Weight Loss Reduce the Risk of Breast Cancer: A Meta-analysis of 139 Prospective and Retrospective Studies. Clin Breast Cancer. 2018 Aug;18(4):e601-e612. doi: 10.1016/j.clbc.2017.10.010. Epub 2017 Oct 17.
- Background: PubMed 28260236van den Brandt PA, Schulpen M. Mediterranean diet adherence and risk of postmenopausal breast cancer: results of a cohort study and meta-analysis. Int J Cancer. 2017 May 15;140(10):2220-2231. doi: 10.1002/ijc.30654. Epub 2017 Mar 5.
- Background: PubMed 19026373Christou NV, Lieberman M, Sampalis F, Sampalis JS. Bariatric surgery reduces cancer risk in morbidly obese patients. Surg Obes Relat Dis. 2008 Nov-Dec;4(6):691-5. doi: 10.1016/j.soard.2008.08.025. Epub 2008 Sep 20.
- Background: PubMed 19148123Adams TD, Stroup AM, Gress RE, Adams KF, Calle EE, Smith SC, Halverson RC, Simper SC, Hopkins PN, Hunt SC. Cancer incidence and mortality after gastric bypass surgery. Obesity (Silver Spring). 2009 Apr;17(4):796-802. doi: 10.1038/oby.2008.610. Epub 2009 Jan 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia C Tchou, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight-loss Program Via Telehealth, Behavioral Weight-Loss Program Via Telehealth - Weight Measures and Validated Surveys of Patient-Reported Outcomes in people with Cancer Survivors and Cancer of Breast, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855552, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.