ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial (NCT06038032) | Clinical Trial Compass
RecruitingNot Applicable
ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial
Canada148 participantsStarted 2024-03-25
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Change from baseline in waist circumference at week 16.