Tests a digital wellness program for endometrial cancer survivors' health

Trial details

Who runs it

University of Alberta

Trial code

NCT06038032

Record updated

21 September 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: ≥ 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; Self-reported BMI ≥25 and ≤45 kg/m2, or self-reported BMI ≥18.5 and ≤24.9 kg/m2 together with a cardiometabolic condition or waist circumference ≥80 cm. Cardiometabolic conditions are also self-reported and included type 2 diabetes, prediabetes, hypertension, dyslipidemia, coronary artery disease, and stroke among others; 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: Weight fluctuations (±5 kg) within the previous 3 months; Planned surgery in the next 6 months; Previous bariatric surgery; Taking corticosteroids; Taking anti-obesity drugs; Active substance abuse (alcohol, cannabis, illicit drugs, prescription drugs); Uncontrolled thyroid disorder; Type 1 diabetes; 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; Self-reported history of an eating disorder diagnosed by a physician; 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.); Type 2 diabetes with HbA1c > 10% or are taking insulin, sulfonylureas, or GLP-1 agonists; Recurrent (local, regional, or distant) or metastatic EC; Abnormal (i.e., mutated) p53 status in combination with FIGO 2009 stage III or IV; 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; 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; Intending to be away longer than 2 weeks consecutively during the intervention and unable to adhere to the study protocol during this period; 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 come to study location; Unable to provide written informed consent.

ClinicalTrials.gov NCT06038032