Web-based Lifestyle Program, mHealth and EMA Intervention, to Improve Weight Loss in Rural Stage … (NCT07723235) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Web-based Lifestyle Program, mHealth and EMA Intervention, to Improve Weight Loss in Rural Stage I-III Postmenopausal Breast and Endometrial Cancer Survivors, HERO-C Trial
United States90 participantsStarted 2026-10-10
Plain-language summary
This clinical trial identifies the needs and preferences of rural stage I-III postmenopausal breast and endometrial cancer survivors and evaluates the impact of an adaptive, online program, mobile (m)Health + ecological momentary assessment (EMA) intervention, on lifestyle modification and their weight loss efforts. Obesity, a condition marked by an abnormally high, unhealthy amount of body fat, is associated with lower physical and psychological well-being, higher risk of recurrence, and higher cancer-specific and all-cause mortality (number of deaths). Lifestyle factors, such as low physical activity and unhealthy diet, are the main contributors to obesity that are modifiable. Lifestyle weight loss programs focusing on modifiable factors can improve cancer-specific survival and many aspects of health, but access to these programs can be challenging in rural settings. A remote lifestyle program, adapted to individual goals and needs, may help promote healthy behaviors, improve cancer outcomes, and reduce disease burden in stage I-III postmenopausal breast and endometrial cancer survivors.
Who can participate
Age range
40 Years – 69 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body mass index (BMI) ≥ 25kg/m\^2
* Age: 40-69 years
* 1-5 years post-diagnosis of stage I-III postmenopausal breast cancer or stage I-III endometrial cancer
* No known evidence of recurrence (local or distant) or second, primary cancer
* No prior history of new other malignancy since their breast or endometrial cancer diagnosis (other than non-melanoma skin cancer)
* Not currently participating in any weight loss programs, no personal trainer, and not meeting the physical activity guidelines
* No use of any anti-obesity medications in the last 6 months and no plan to start anti-obesity medications during the study period
* The ability to walk two blocks without a walker or cane
* The ability to speak and read English
* Have access to internet with a computer, tablet, or smart phone
* Live in rural counties in Ohio and not planning to move away during the study
* Are not pregnant, breastfeeding or less than 12-month post-partum and do not plan to become pregnant during the study
Exclusion Criteria:
* Severe medical conditions, such as unstable cardiovascular disease or digestive disorders, that would preclude physical activity and dietary intervention
* Lack of physician clearance if determined necessary by the Physical Activity Readiness Questionnaire (PAR-Q+)
* Acute physical limitations for unsupervised exercises at home
* Unable to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Preferences, needs and satisfaction (Aim 1a)
Timeframe: At pre- and post-intervention, assessed up to week 26
2
Percentage of early non-responders who complete the mobile Health + ecological momentary assessment intervention (Aim 1b)
Timeframe: Up to week 26
3
Percentage of all participants who complete all assessments (Aim 1c)
Timeframe: Up to week 26
4
Changes in weight (Aim 2)
Timeframe: At baseline (T0), at week 4 (T1), and at week 26 (T2)
5
Changes in muscle mass (Aim 2)
Timeframe: At baseline (T0), at week 4 (T1), and at week 26 (T2)
6
Changes in metabolic profiles (Aim 2)
Timeframe: At baseline (T0), at week 4 (T1), and at week 26 (T2)
7
Changes in inflammatory markers (Aim 2)
Timeframe: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Trial details
NCT IDNCT07723235
SponsorOhio State University Comprehensive Cancer Center
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-12-31
Contact for this trial
The Ohio State University Comprehensive Cancer Center