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

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

Interventions

OTHER

Aerobic Exercise

Participate in moderate-intensity aerobic physical activity

PROCEDURE

Biospecimen Collection

Undergo urine and blood sample collection

OTHER

Dietary Intervention

Adhere to a personalized diet

OTHER

Discussion

Participate in a focus group

OTHER

Goal Setting

Set goals for behavioral changes

OTHER

Internet-Based Intervention

Complete self-paced web-based lifestyle program modules

OTHER

Medical Device Usage and Evaluation

Wear a physical activity tracker

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Resistance Training

Participate in resistance training

BEHAVIORAL

Smartphone Application-based Intervention

Receive access to the Fitbit app

OTHER

Supportive Care

Receive access to online resources

OTHER

Supportive Care

Attend virtual group sessions

PROCEDURE

Tailored Intervention

Receive JITAI tailored resource components

Sponsors & Collaborators

• American Association for Cancer Research

  collaborator OTHER

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

40 Years

Max Age

69 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-10

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United States

Study Locations