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Anatomic Stage I Breast Cancer AJCC v8NCT07723235

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

A study testing Aerobic Exercise, Biospecimen Collection and Dietary Intervention in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 40 to 69 years, women only
What is being tested?
Aerobic Exercise, Biospecimen Collection and Dietary Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
10 Oct 2026to 31 Dec 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 69 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Xiaochen Zhang, PhD, 614-685-0624, Xiaochen.Zhang@osumc.edu

    Xiaochen Zhang, PhD

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Aerobic Exercise, Biospecimen Collection, Dietary Intervention, Discussion, Goal Setting
Medical subject headings
Endometrial Neoplasms, Carcinosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseOther

    Also called Aerobic Activity

    Participate in moderate-intensity aerobic physical activity

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo urine and blood sample collection

  • Dietary InterventionOther

    Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions

    Adhere to a personalized diet

  • DiscussionOther

    Also called Discuss

    Participate in a focus group

  • Goal SettingOther

    Set goals for behavioral changes

  • Internet-Based InterventionOther

    Complete self-paced web-based lifestyle program modules

  • Medical Device Usage and EvaluationOther

    Wear a physical activity tracker

  • Questionnaire AdministrationOther

    Ancillary studies

  • Resistance TrainingOther

    Also called Strength Training

    Participate in resistance training

  • Smartphone Application-based InterventionBehavioural

    Also called Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention

    Receive access to the Fitbit app

  • Supportive CareOther

    Also called Supportive Therapy, Symptom Management, Therapy, Supportive

    Receive access to online resources

  • Supportive CareOther

    Also called Supportive Therapy, Symptom Management, Therapy, Supportive

    Attend virtual group sessions

  • Tailored InterventionProcedure or surgery

    Receive JITAI tailored resource components

Study groups in NCT07723235
Study groupRoleWhat they receive
Group I (web-based lifestyle program, virtual group)ExperimentalPHASE 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.
Receives: 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)ExperimentalPHASE 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

    Will report the frequency, proportion, and 95% confidence intervals (CIs) of early non-responders who completed the intervention.

    Measured: Up to week 26

  3. 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.

    Measured: Up to week 26

  4. 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).

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

  5. Changes in muscle mass (Aim 2)

    Will estimate the preliminary effect size using linear mixed models.

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

  6. Changes in metabolic profiles (Aim 2)

    Will estimate the preliminary effect size using linear mixed models.

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

  7. Changes in inflammatory markers (Aim 2)

    Will estimate the preliminary effect size using linear mixed models.

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

  8. Changes in behaviors (Aim 2)

    Will estimate the preliminary effect size using linear mixed models.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2026
  2. Study start10 Oct 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Model description
Patients complete Phase I and then assigned to either group 1 or 2 in Phase 2.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07723235
Sponsor's protocol ID
OSU-26016
Other IDs
NCI-2026-05189, STUDY20252952
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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