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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

ConditionsAnatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Endometrial CarcinomaStage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8Stage II Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-69
SponsorOhio State University Comprehensive Cancer Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body mass index (BMI) ≥ 25kg/m²

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

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • Aerobic Exercise

    Other intervention

    Participate in moderate-intensity aerobic physical activity

  • Biospecimen Collection

    Procedure/Surgery

    Undergo urine and blood sample collection

  • Dietary Intervention

    Other intervention

    Adhere to a personalized diet

  • Discussion

    Other intervention

    Participate in a focus group

  • Goal Setting

    Other intervention

    Set goals for behavioral changes

  • Internet-Based Intervention

    Other intervention

    Complete self-paced web-based lifestyle program modules

  • Medical Device Usage and Evaluation

    Other intervention

    Wear a physical activity tracker

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Resistance Training

    Other intervention

    Participate in resistance training

  • Smartphone Application-based Intervention

    Behavioral

    Receive access to the Fitbit app

  • Supportive Care

    Other intervention

    Receive access to online resources

  • Supportive Care

    Other intervention

    Attend virtual group sessions

  • Tailored Intervention

    Procedure/Surgery

    Receive JITAI tailored resource components

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Group I (web-based lifestyle program, virtual group)Experimental treatment 8 interventions
Group B: Group II (web-based lifestyle, JITAI)Experimental treatment 12 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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).

Time frame
At baseline (T0), at week 4 (T1), and at week 26 (T2)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

American Association for Cancer Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: