Web-based Lifestyle Program, mHealth and EMA Intervention, to Improve Weight Loss in Rural Stage I-III Postmenopausal Breast and Endometrial... | NCT07723235

NCT07723235

Overview

NCT ID: NCT07723235
Lead Sponsor: Ohio State University Comprehensive Cancer CenterOTHER
Official Title: Health Engagement for Rural Ohio Cancer Survivors (HERO-C)
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Oct 10, 2026Estimated
Primary Completion Date: Dec 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
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 Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 90Estimated
Primary Purpose: Supportive Care
Allocation: Non-Randomized
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: The Ohio State University Comprehensive Cancer CenterContact
OSUCCCClinicaltrials@osumc.edu

Similar Studies

Participant Group/Arms

Group I (web-based lifestyle program, virtual group)Experimental

PHASE I (WEEKS 1-4): Patients complete self-paced web-based lifestyle program modules over 45-90 minutes weekly for 4 weeks. Patients adhere to a personalized diet meeting AICR guidelines and receive access to online resources, including AICR resources, online cooking class videos, healthy eating recipes and tips. Patients participate in moderate-intensity aerobic physical activity over 10-30 minutes on 5 days weekly and resistance training over 30 minutes on 2-3 times weekly. PHASE II (WEEKS 5-26): Patients continue web-based program modules, exercise program and diet recommendations as in Phase I. Patients also attend virtual group sessions over 45-50 minutes weekly for weeks 5-26. Patients may also participate in a focus group over 30-45 minutes on study. Additionally, patients undergo urine and blood sample collection throughout the study.

Other: Aerobic Exercise

Procedure: Biospecimen Collection

Other: Dietary Intervention

Other: Discussion

Other: Internet-Based Intervention

Other: Questionnaire Administration

Other: Resistance Training

Other: Supportive Care

Group II (web-based lifestyle, JITAI)Experimental

PHASE I (WEEKS 1-4): Patients complete self-paced web-based lifestyle program modules over 45-90 minutes weekly for 4 weeks. Patients adhere to a personalized diet meeting AICR guidelines and receive access to online resources, including AICR resources, online cooking class videos, healthy eating recipes and tips. Patients participate in moderate-intensity aerobic physical activity over 10-30 minutes on 5 days weekly and resistance training over 30 minutes on 2-3 times weekly. PHASE II (WEEKS 5-26): Patients continue web-based program modules, exercise program and diet recommendations as in Phase I. Patients also set goals for behavioral changes weekly and receive JITAI tailored resource components via mHealth + EMA during weeks 5-26. Patients wear a physical activity tracker daily and receive access to the Fitbit App. Patients may also participate in a focus group over 30-45 minutes on study. Patients undergo urine and blood sample collection throughout the study.