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

July 20, 2026 updated by: Xiaochen Zhang, Ohio State University Comprehensive Cancer Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the feasibility of an mHealth + EMA intervention in addition to the web-based lifestyle program with remote outcome assessments among rural breast and endometrial cancer survivors. (Aim 1) Ia. To identify rural cancer survivors' perspectives and unique needs/challenges of participating in a web-based lifestyle program via focus groups pre- and post-intervention (n=20); (Aim 1a) Ib. To determine the feasibility of mHealth + EMA among early non-responders (week 5-26); (Aim 1b) Ic. To determine the feasibility of remote outcome assessments. (Aim 1c) II. To determine the preliminary efficacy of the additional mHealth + EMA intervention for early non-responders from the web-based lifestyle program (within-person change from week 5-26). (Aim 2)

EXPLORATORY OBJECTIVE:

I. To explore the differences in metabolomic, inflammatory, behavioral, and psychosocial factors between early responders and early non-responders at baseline, month 1 and month 6.

OUTLINE:

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 American Institute of Cancer Research (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 are assigned to 1 of 2 groups based on Phase I progress.

GROUP I (EARLY RESPONDER): 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.

GROUP II (EARLY NON-RESPONDER): 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 just-in-time adaptive interventions (JITAI) tailored resource components via mHealth + EMA during weeks 5-26. Patients wear a physical activity tracker daily and receive access to the Fitbit application (App).

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.

After completion of study intervention, patients may follow up in 6 months.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Xiaochen Zhang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (web-based lifestyle program, virtual group)

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: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Other: Aerobic Exercise
Participate in moderate-intensity aerobic physical activity
Other Names:
  • Aerobic Activity
Other: Dietary Intervention
Adhere to a personalized diet
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Other: Discussion
Participate in a focus group
Other Names:
  • Discuss
Other: Internet-Based Intervention
Complete self-paced web-based lifestyle program modules
Other: Resistance Training
Participate in resistance training
Other Names:
  • Strength Training
Other: Supportive Care
Receive access to online resources
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Other: Supportive Care
Attend virtual group sessions
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Experimental: Group II (web-based lifestyle, JITAI)

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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Other: Aerobic Exercise
Participate in moderate-intensity aerobic physical activity
Other Names:
  • Aerobic Activity
Other: Dietary Intervention
Adhere to a personalized diet
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Other: Discussion
Participate in a focus group
Other Names:
  • Discuss
Other: Internet-Based Intervention
Complete self-paced web-based lifestyle program modules
Other: Resistance Training
Participate in resistance training
Other Names:
  • Strength Training
Other: Supportive Care
Receive access to online resources
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Other: Supportive Care
Attend virtual group sessions
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Other: Goal Setting
Set goals for behavioral changes
Other: Medical Device Usage and Evaluation
Wear a physical activity tracker
Behavioral: Smartphone Application-based Intervention
Receive access to the Fitbit app
Other Names:
  • Smartphone App-based Intervention
  • Smartphone Intervention
  • Smartphone-based Intervention
Procedure: Tailored Intervention
Receive JITAI tailored resource components

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preferences, needs and satisfaction (Aim 1a)
Time Frame: At pre- and post-intervention, assessed up to week 26
Focus groups will be audio recorded through online videoconference (e.g. Teams) and transcribed using NVivo. Content analysis will be conducted to identify patterns, themes, and perspectives from participants using NVivo coding or similar software. When possible, the frequency, intensity, and context of certain perspectives will be described. Similarly, thematic analysis will be conducted using NVivo to identify themes (e.g., likes/dislikes, motivations, expectations) and mapped to potential intervention components.
At pre- and post-intervention, assessed up to week 26
Percentage of early non-responders who complete the mobile Health + ecological momentary assessment intervention (Aim 1b)
Time Frame: Up to week 26
Will report the frequency, proportion, and 95% confidence intervals (CIs) of early non-responders who completed the intervention.
Up to week 26
Percentage of all participants who complete all assessments (Aim 1c)
Time Frame: Up to week 26
Will report the frequency, proportion, and 95% CIs of all participants who completed outcome assessments.
Up to week 26
Changes in weight (Aim 2)
Time Frame: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Linear mixed models will be used to account for repeated measures, with random effects for the individual. The linear mixed models will use all available data under a missing-at-random assumption and will assess potential attrition bias by comparing baseline/week 4 characteristics of completers versus non-completers, with sensitivity analyses is missingness appears outcome-related. Will report the preliminary effect size as within-person changes on weight (from week 4 to week 26).
At baseline (T0), at week 4 (T1), and at week 26 (T2)
Changes in muscle mass (Aim 2)
Time Frame: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Will estimate the preliminary effect size using linear mixed models.
At baseline (T0), at week 4 (T1), and at week 26 (T2)
Changes in metabolic profiles (Aim 2)
Time Frame: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Will estimate the preliminary effect size using linear mixed models.
At baseline (T0), at week 4 (T1), and at week 26 (T2)
Changes in inflammatory markers (Aim 2)
Time Frame: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Will estimate the preliminary effect size using linear mixed models.
At baseline (T0), at week 4 (T1), and at week 26 (T2)
Changes in behaviors (Aim 2)
Time Frame: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Will estimate the preliminary effect size using linear mixed models.
At baseline (T0), at week 4 (T1), and at week 26 (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

American Association for Cancer Research

Investigators

  • Principal Investigator: Xiaochen Zhang, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 10, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-26016
  • NCI-2026-05189 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • STUDY20252952

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anatomic Stage I Breast Cancer AJCC v8

Clinical Trials on Questionnaire Administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe