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

NCT07723235 | Not Yet Recruiting DMC

• 3 other identifiers: OSU-26016NCI-2026-05189STUDY20252952
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Endometrial Carcinoma; Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8; Stage II Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8; Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Outcome Measures

Primary Outcomes (8)

• Preferences, needs and satisfaction (Aim 1a)

  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)

  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)

  Will report the frequency, proportion, and 95% CIs of all participants who completed outcome assessments.

  Up to week 26

• Changes in weight (Aim 2)

  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)

  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)

  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)

  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)

  Will estimate the preliminary effect size using linear mixed models.

  At baseline (T0), at week 4 (T1), and at week 26 (T2)

Study Arms (2)

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.

Other: Aerobic Exercise; Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Discussion; Other: Goal Setting; Other: Internet-Based Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Resistance Training; Behavioral: Smartphone Application-based Intervention; Other: Supportive Care; Procedure: Tailored Intervention

Interventions

Aerobic Exercise OTHER

Participate in moderate-intensity aerobic physical activity

Also known as: Aerobic Activity

Group I (web-based lifestyle program, virtual group); Group II (web-based lifestyle, JITAI)

Biospecimen Collection PROCEDURE

Undergo urine and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Group I (web-based lifestyle program, virtual group); Group II (web-based lifestyle, JITAI)

Dietary Intervention OTHER

Adhere to a personalized diet

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Group I (web-based lifestyle program, virtual group); Group II (web-based lifestyle, JITAI)

Discussion OTHER

Participate in a focus group

Also known as: Discuss

Group I (web-based lifestyle program, virtual group); Group II (web-based lifestyle, JITAI)

Goal Setting OTHER

Set goals for behavioral changes

Group II (web-based lifestyle, JITAI)

Medical Device Usage and Evaluation OTHER

Wear a physical activity tracker

Group II (web-based lifestyle, JITAI)

Questionnaire Administration OTHER

Ancillary studies

Group I (web-based lifestyle program, virtual group); Group II (web-based lifestyle, JITAI)

Resistance Training OTHER

Participate in resistance training

Also known as: Strength Training

Group I (web-based lifestyle program, virtual group); Group II (web-based lifestyle, JITAI)

Smartphone Application-based Intervention BEHAVIORAL

Receive access to the Fitbit app

Also known as: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention

Group II (web-based lifestyle, JITAI)

Supportive Care OTHER

Receive access to online resources

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Group I (web-based lifestyle program, virtual group); Group II (web-based lifestyle, JITAI)

Tailored Intervention PROCEDURE

Receive JITAI tailored resource components

Group II (web-based lifestyle, JITAI)

Internet-Based Intervention OTHER

Complete self-paced web-based lifestyle program modules

Group I (web-based lifestyle program, virtual group); Group II (web-based lifestyle, JITAI)

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) ≥ 25kg/m\^2
• Age: 40-69 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• American Association for Cancer Research: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Endometrial Neoplasms; Carcinosarcoma

Interventions

Exercise; Specimen Handling; Diet Therapy; Organizational Objectives; Resistance Training; Palliative Care

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Nutrition Therapy; Therapeutics; Organization and Administration; Health Services Administration; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Xiaochen Zhang, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients complete Phase I and then assigned to either group 1 or 2 in Phase 2.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

US (1)