Clinical trial · Interventional
Physical Activity Promotion for Breast and Endometrial Cancer Survivors
Multi-site Adaptive Trial of a Technology-based, EHR-integrated Physical Activity Intervention in Breast and Endometrial Cancer Survivors
- 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)
Many breast and endometrial cancer survivors do not get enough physical activity. Technology-based interventions can be inexpensive and easy to scale up, however they are not effective for all women. The purpose of this study is test an adaptive physical activity intervention approach that reserves the most resources and support for women who do not fare well with a lower-cost, minimal intervention. The results from this trial will inform the development of scalable physical activity interventions for breast and endometrial cancer survivors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
| Endometrial Cancer Survivors | — | UNRESOLVED | — |
| Physical Activity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Base intervention-Fitbit with EHR integration | Other | — | UNRESOLVED |
| Coaching Calls | Other | — | UNRESOLVED |
| Online Gym | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Base intervention- Fitbit with EHR integration
- description
- All participants will receive a first-line intervention (i.e., Fitbit activity tracker with EHR integration including messages delivered via the EHR's patient portal) and will be evaluated for response/non-response every 4 weeks until week 20.
- interventionNames
- Other: Base intervention-Fitbit with EHR integration
- type
- EXPERIMENTAL
- label
- Nonresponders -Stepped up to Online gym
- description
- Non-responders to 'fitbit with EHR integration' will be randomized to be "stepped up" to one of two augmentation strategies(either Online gym or coaching calls). This arm will be stepped up to Online gym.
- interventionNames
- Other: Base intervention-Fitbit with EHR integration
- Other: Online Gym
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female adult (≥18 years of age) * Diagnosis of Stage I-III breast or Stage I-II Type 1 endometrial cancer within the past 5 years. * At least 3 months past completion of primary active treatment (i.e., surgery, chemotherapy, and/or radiation). May still be undergoing endocrine or Human epidermal growth factor receptor 2 (Her2) therapies. * Insufficiently active, defined as ≤60 min/week of MVPA, performed in bouts of ≥10 minutes.This is 40% of the recommended amount of MVPA based on the 2008 Federal Guidelines and the American Cancer Society's guidelines for cancer survivors. The 7-Day Recall will be used to screen for physical activity; eligibility will be confirmed prior to randomization using the ActiGraph accelerometer. * Able to access high-speed Internet daily at home on a computer, smartphone, or tablet. Internet access may be through a household connection or a wireless provider (e.g., Verizon, AT\&T). For compatibility with the Fitbit, the device must run a Windows, Apple, or Android operating system. * Have a MyChart account or be willing to create one. * Fluent in spoken and written English language. * For safety, participants will be screened using the Physical Activity Readiness Questionnaire (PAR-Q) and the Falls Risk Screener, which address joint and cardiovascular problems, balance issues, and other concerns. Physician consent will be obtained for all participants who meet the following criteria: * Answer yes to ≥1 question on the PAR-Q OR * Answer yes to ≥4 questions on the Falls Risk Screener * Willing and able to attend study visits at the University of Wisconsin, Madison or Northwestern University, Chicago * Own and can use a smartphone Exclusion Criteria: * Any absolute contraindications to exercise (i.e. acute myocardial infarction, severe orthopedic conditions), metastatic disease or planned elective surgery during intervention/ follow-up. * Self-reported difficulty transitioning walking 1 block (as a proxy measure of basic physical functioning), or inability to work towards the intervention goals * Plans to become pregnant or to move from the area within the next two years * Current enrollment in another dietary or physical activity trial
References
Publications (1)
- DERIVEDCadmus-Bertram L, Solk P, Agnew M, Starikovsky J, Schmidt C, Morelli WA, Hodgson V, Freeman H, Muller L, Mishory A, Naxi S, Carden L, Tevaarwerk AJ, Wolter M, Barber E, Spencer R, Sesto ME, Gradishar W, Gangnon R, Spring B, Nahum-Shani I, Phillips SM. A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol. Contemp Clin Trials. 2023 Jul;130:107187. doi: 10.1016/j.cct.2023.107187. Epub 2023 Apr 21. PMID 37086916