ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial

The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.

RESILIENCE is 24-week randomized controlled trial that assesses the efficacy of a digital wellness platform, combined with online support from healthcare professionals, to enhance waist circumference and other vital health outcomes in endometrial cancer survivors.

Background: Individuals diagnosed with endometrial cancer are at an increased risk of cardiac complications post-treatment, particularly if having overweight or a pronounced waist size. Adopting healthy habits-like nutritious eating, regular physical activity, and effective stress management-can mitigate these risks and bolster overall health. However, many cancer survivors find it challenging to consistently adhere to these health and wellness recommendations.

Objective: This study aims to determine the efficacy of a digital wellness platform, enriched with professional guidance, in facilitating healthier lifestyles for endometrial cancer survivors. This would encompass enhancements in nutrition, physical activity levels, and mindfulness practices.

Study Design:

Group 1 (Intervention Group): Participants will engage with the digital wellness platform daily for the initial 16 weeks with expert guidance. Subsequently, participants will navigate the platform independently for the next 8 weeks.

Group 2 (Control Group): Participants will initially be provided with standard publicly accessible health information. After the primary 24-week period, participants will gain access to the digital wellness platform.

Common Elements: Both groups will have access to general health information and will benefit from supportive calls. To monitor their physical activity, all participants will be equipped with an activity tracker.

Inclusion Criteria:

• ≥ 18 years old
• Histologically confirmed endometrioid adenocarcinoma (low-grade), FIGO 2009 stages I to III.
• 1 month to 10 years post-surgery and completion of adjuvant treatment.
• BMI ≥25 and ≤45 kg/m2.
• Willing and able to adhere to the study interventions and assessments
• Seeking best weight using the readiness to change questionnaire.
• Have a cell phone compatible with the Fitbit app with internet access and Bluetooth capabilities.
• Able to speak, read and understand English.

Exclusion Criteria:

• Recurrent (local, regional, or distant) or metastatic EC.
• Abnormal (i.e., mutated) p53 status in combination with FIGO 2009 stage III or IV
• Weight fluctuations (±5 kg) within the previous 3 months.
• Planned surgery in the next 6 months.
• Previous bariatric surgery.
• Uncontrolled thyroid disorder
• Type 1 diabetes.
• Type 2 diabetes with HbA1c > 10% or are taking insulin, sulfonylureas, or GLP-1 agonists.
• Taking corticosteroids.
• Taking anti-obesity drugs.
• Current smoker (of any type, e.g e-cigarettes, tobacco, marihuana, vaping)
• Self-report >90 moderate-intensity min/week of aerobic physical activity on average over the past three months.
• Potential safety risk with exercise or maximal exercise testing screened with the 2023 Physical Activity Readiness Questionnaire (PAR-Q+)53, signs and symptoms of CVD, and any of the American Heart Association's absolute or relative contraindications to exercise testing.
• Physical or mobility limitations impacting ability to perform physical activity.
• Self-report following a structured hypocaloric diet (e.g., using formulated meal replacements, weight loss meal program) or a restrictive diet (intermittent fasting, or high-fat diet) in the past three months, or self-report currently following a vegan diet but for less than two years.
• Self-reported history of an eating disorder diagnosed by a physician.
• Intending to be away longer than 2 weeks consecutively during the intervention and unable to adhere to the study protocol during this period.
• Active substance abuse (alcohol, cannabis, illicit drugs, prescription drugs).
• Dual-energy x-ray absorptiometry (DXA) or magnetic resonance imaging (MRI) contraindications for research purposes, such as pacemakers or pregnancy
• Unable to participate in telephone and virtual intervention protocols (e.g., having a severe hearing or vision loss).
• Unable to adhere to the study protocol (i.e., unavailable to commit to scheduled group video conferencing sessions; limited access to the Internet; not willing to use platform, individuals who have been advised by a health professional not to lose weight or reduce caloric intake; cognitive impairment or dementia; etc.).
• Unable to come to study location.
• Unable to provide written informed consent.