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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

Health Engagement for Rural Ohio Cancer Survivors (HERO-C)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 69 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "OUTLINE: PHASE I (WEEKS 1-4): Patients complete self-paced web-based lifestyle program modules over 45-90 minutes weekly for 4 weeks."
  • "Additionally, patients undergo urine and blood sample collection throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an online program with mobile tools and check-ins to help people build healthy habits and lose weight. It is for rural survivors of stage I–III breast or endometrial cancer (cancer of the womb lining) who have gone through menopause. The program is shaped around each person's goals and needs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40–69, with a body mass index (BMI) of 25 or higher. BMI is a measure of weight compared with height.
  • Diagnosed 1–5 years ago with stage I–III breast cancer after menopause or stage I–III endometrial cancer.
  • No known return of cancer or new, separate cancer since diagnosis, except non-melanoma skin cancer.
  • Not in a weight loss program, not using a personal trainer, and getting less exercise than activity guidelines recommend.
  • No weight loss medicines in the past 6 months and no plans to start them during the study.
  • Able to walk two blocks without a cane or walker, and able to speak and read English.
  • Have internet access on a computer, tablet, or smartphone. Live in a rural Ohio county and plan to stay during the study.
  • Not pregnant or breastfeeding, have not given birth in the past 12 months, and do not plan to become pregnant during the study.

Who can't join

  • A serious health problem, such as unstable heart disease or a digestive disorder, that prevents exercise or diet changes.
  • No doctor's approval if the exercise safety questionnaire shows that approval is needed.
  • A current physical problem that prevents safe exercise at home without supervision.
  • Unable to give informed consent, meaning agreeing to join after understanding the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

OH