NCT06038032Recruiting
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.
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- First submitted
- 24 Aug 2023
- Start date
- 25 Mar 2024
- Primary completion date
- Mar 2028
- Lead sponsor
- University of Alberta
- Diseases
- Endometrial cancer
- NCT number
- NCT06038032
What you commit to
- Study type: Interventional
- Planned participants: 148
- From 25 Mar 2024 to the primary completion date, Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.).
Lab values
- Type 2 diabetes with HbA1c \> 10% or are taking insulin, sulfonylureas, or GLP-1 agonists.
Other
- 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.
Who the study is looking for
- ≥ 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.
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| University of Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.