The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Cancer
- Sponsor
- University of Alberta
- Enrollment
- 148
- Locations
- 2
- Primary Endpoint
- Change from baseline in waist circumference at week 16.
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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 and other vital health outcomes in endometrial cancer survivors.
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 healthy habits-like nutritious eating, regular physical activity, and effective stress management-can mitigate these risks and bolster overall health. However, many cancer survivors find it challenging to consistently adhere to these health and wellness recommendations. Objective: This study aims to determine the efficacy of a digital wellness platform, enriched with professional guidance, in facilitating healthier lifestyles for endometrial cancer survivors. This would encompass enhancements in nutrition, physical activity levels, and mindfulness practices. Study Design: Group 1 (Intervention Group): Participants will engage with the digital wellness platform daily for the initial 16 weeks with expert guidance. Subsequently, participants will navigate the platform independently for the next 8 weeks. Group 2 (Control Group): Participants will initially be provided with standard publicly accessible health information. After the primary 24-week period, participants will gain access to the digital wellness platform. Common Elements: Both groups will have access to general health information and will benefit from supportive calls. To monitor their physical activity, all participants will be equipped with an activity tracker.
Investigators
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.
- •BMI ≥25 and ≤45 kg/m
- •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.
Outcomes
Primary Outcomes
Change from baseline in waist circumference at week 16.
Time Frame: Baseline to week 16
Waist circumference will be measured in centimeters (cm) using an inelastic tape at the level of the iliac crest at the end of normal expiration.
Secondary Outcomes
- Change from baseline in appendicular lean soft tissue by DXA at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in handgrip muscle strength at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in adipose tissue in liver by MRI at week 24.(Baseline and week 24)
- Change from baseline in cardiorespiratory fitness by a cardiopulmonary exercise testing (CPET) at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in waist circumference at week 24.(Baseline and week 24)
- Change from baseline in carotid intima-media thickness by ultrasound at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in abdominal skeletal muscle by MRI at week 24.(Baseline and week 24)
- Change from baseline in adipose tissue in the thigh region by MRI at week 24.(Baseline and week 24)
- Change from baseline in cardiac function by MRI at week 24.(Baseline and week 24)
- Change from baseline in body weight (in kg) at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in health-related life improvement by the QLQ-C30 at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in fat mass by DXA at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in metabolic syndrome by Z score calculation at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in cardiovascular risk based on the Framingham risk score at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in health-related life improvement by the QLQ-EN24 at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in abdominal adiposity by MRI at week 24.(Baseline and week 24)
- Change from baseline in skeletal muscle in the thigh region by MRI at week 24.(Baseline and week 24)