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

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.

• Aerobic Exercise (Other), also known as Aerobic Activity: Participate in moderate-intensity aerobic physical activity
• Biospecimen Collection (Procedure), also known as Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection: Undergo urine and blood sample collection
• Dietary Intervention (Other), also known as Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions: Adhere to a personalized diet
• Discussion (Other), also known as Discuss: 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), also known as Strength Training: Participate in resistance training
• Smartphone Application-based Intervention (Behavioral), also known as Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention: Receive access to the Fitbit app
• Supportive Care (Other), also known as Supportive Therapy, Symptom Management, Therapy, Supportive: Receive access to online resources
• Supportive Care (Other), also known as Supportive Therapy, Symptom Management, Therapy, Supportive: Attend virtual group sessions
• Tailored Intervention (Procedure): Receive JITAI tailored resource components

Primary outcomes

• 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.

Sex: Female, ages: 40 Years to 69 Years

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

• Xiaochen Zhang, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center