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

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

Eligibility Criteria

Sex

FEMALE

Age

40 Years - 69 Years

Healthy Volunteers

Not accepted

Interventions

• Aerobic Exercise — OTHER
  Participate in moderate-intensity aerobic physical activity
• Biospecimen Collection — PROCEDURE
  Undergo urine and blood sample collection
• Dietary Intervention — OTHER
  Adhere to a personalized diet
• Discussion — OTHER
  Participate in a focus group
• 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
• Smartphone Application-based Intervention — BEHAVIORAL
  Receive access to the Fitbit app
• Supportive Care — OTHER
  Receive access to online resources
• Supportive Care — OTHER
  Attend virtual group sessions
• Tailored Intervention — PROCEDURE
  Receive JITAI tailored resource components

Study Details

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.

Key Dates

First listed

Jul 23, 2026

Start date

Oct 10, 2026

Status verified

Jul 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

90 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Group I (web-based lifestyle program, virtual group)
  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.
• Experimental: Group II (web-based lifestyle, JITAI)
  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.

Primary Outcome Measure

Preferences, needs and satisfaction (Aim 1a) [ Time Frame: At pre- and post-intervention, assessed up to week 26 ]

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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