Clinical trial · Interventional
Telehealth Weight Loss Program for Breast Cancer Survivors
Pilot Telehealth Weight Loss Program for Breast Cancer Survivors
NCT04855552CI-TRIAL-00122021TWLactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Weight | — | UNRESOLVED | — |
| Cancer of Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer Survivors | — | UNRESOLVED | — |
| Overweight and Obesity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Weight-loss Program Via Telehealth | Behavioral | — | UNRESOLVED |
| Behavioral Weight-Loss Program Via Telehealth - Weight Measures | Behavioral | — | UNRESOLVED |
| Validated Surveys of Patient-Reported Outcomes | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-Arms Longitudinal Group
- description
- 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.
- interventionNames
- Behavioral: Behavioral Weight-loss Program Via Telehealth
- Behavioral: Behavioral Weight-Loss Program Via Telehealth - Weight Measures
- Behavioral: Validated Surveys of Patient-Reported Outcomes
Primary outcomes (5)
- measure
- Determine feasibility and Acceptability Using the City of Hope Quality of Life Instrument - Breast Cancer Patient to Assess Changes in Quality of Life
- timeFrame
- 24 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (25)
- BACKGROUNDGoodwin 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. PMID 32133391
- BACKGROUNDLigibel 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. PMID 28948213
- BACKGROUNDKrouse 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. PMID 26804708
- BACKGROUNDWilliams 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. PMID 28660430
- BACKGROUNDEliassen 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. PMID 16835425
- BACKGROUNDParker 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. PMID 14634673