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Recruiting NCT06038032

ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial

Conditions: Endometrial Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 148
Sponsor: University of Alberta

Location: University of Alberta Edmonton Alberta

Summary

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.

Eligibility Criteria

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. * 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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06038032). StuddyBuddy aggregates publicly available trial information.