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NCT Number: 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

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.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Carcinosarcoma Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Sarcoma 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 Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

40 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location contact

Xiaochen Zhang, PhD

CONTACT

[email protected]

614-685-0624

Xiaochen Zhang, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Other

Participate in moderate-intensity aerobic physical activity

Other names: Aerobic Activity

Biospecimen Collection

Procedure

Undergo urine and blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Dietary Intervention

Other

Adhere to a personalized diet

Other names: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Discussion

Other

Participate in a focus group

Other names: Discuss

Goal Setting

Other

Set goals for behavioral changes

Internet-Based Intervention

Other

Complete self-paced web-based lifestyle program modules

Medical Device Usage and Evaluation

Other

Wear a physical activity tracker

Questionnaire Administration

Other

Ancillary studies

Resistance training

Other

Participate in resistance training

Other names: Strength Training

Smartphone Application-based Intervention

Behavioral

Receive access to the Fitbit app

Other names: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention

Supportive Care

Other

Receive access to online resources

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Tailored Intervention

Procedure

Receive JITAI tailored resource components

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • American Association for Cancer Research

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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