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Web-based Lifestyle Program for Breast and Endometrial Cancer Survivors

This study, called the HERO-C Trial, is for women aged 40-69 who have had stage I-III postmenopausal breast cancer or stage I-III endometrial cancer within the last 1-5 years and have a BMI of 25 or higher. It aims to understand the needs of rural cancer survivors and test an online program that includes a web-based lifestyle program, mobile health (mHealth) tools, and ecological momentary assessment (EMA) to help with weight loss. Participants will follow a personalized diet and do moderate-intensity aerobic exercise. The main goals are to see how satisfied participants are with the program and how many complete the interventions and assessments. This research hopes to improve lifestyle changes and weight loss efforts for cancer survivors.

Study design
This interventional study plans to enroll 90 women. It will test an adaptive, online program that includes a web-based lifestyle program, mHealth, and ecological momentary assessment (EMA) intervention.
What's involved
You would participate in a web-based lifestyle program, follow a personalized diet, and do aerobic exercise. You would also provide urine and blood samples, participate in focus groups, and set behavioral goals, with assessments up to week 26.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, including preferences, needs, satisfaction, and completion rates, are measured at pre- and post-intervention, assessed up to week 26.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07723235

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

Not Yet Recruiting
NAAges 40–69InterventionalSupportive care
Ohio State University Comprehensive Cancer Center
~90 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Aerobic ExerciseBiospecimen CollectionDietary InterventionDiscussionGoal SettingInternet-Based Intervention

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Preferences, needs and satisfaction (Aim 1a)
Measured over At pre- and post-intervention, assessed up to week 26
+7 more outcomes measured

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

Explore related trials

Breast CarcinomaEndometrial Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Xiaochen Zhang, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Preferences, needs and satisfaction (Aim 1a)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.

  • Percentage of early non-responders who complete the mobile Health + ecological momentary assessment intervention (Aim 1b)Up to week 26

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

  • Percentage of all participants who complete all assessments (Aim 1c)Up to week 26

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

  • Changes in weight (Aim 2)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).

  • Changes in muscle mass (Aim 2)At baseline (T0), at week 4 (T1), and at week 26 (T2)

    Will estimate the preliminary effect size using linear mixed models.

  • Changes in metabolic profiles (Aim 2)At baseline (T0), at week 4 (T1), and at week 26 (T2)

    Will estimate the preliminary effect size using linear mixed models.

  • Changes in inflammatory markers (Aim 2)At baseline (T0), at week 4 (T1), and at week 26 (T2)

    Will estimate the preliminary effect size using linear mixed models.

  • Changes in behaviors (Aim 2)At baseline (T0), at week 4 (T1), and at week 26 (T2)

    Will estimate the preliminary effect size using linear mixed models.