Status:
RECRUITING
ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial
Lead Sponsor:
University of Alberta
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
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 healt...
Eligibility Criteria
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.
- 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
- 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.
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06038032
Start Date
March 25 2024
End Date
March 1 2028
Last Update
November 18 2025
Active Locations (2)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
2
University of Toronto
Toronto, Canada