Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06038032

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.

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
148 (estimated)
Sponsor
University of Alberta · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDigital wellness platformA digital wellness platform based on preventive self-care that contains tools to monitor nutrition, physical activity, and mental wellbeing will be accessed daily for 24 weeks.
BEHAVIORALOnline healthcare professional supportIndividual sessions with a registered dietitian, an exercise professional, and a mental health therapist for 16 weeks.

Timeline

Start date
2024-03-25
Primary completion
2028-03-01
Completion
2028-03-01
First posted
2023-09-14
Last updated
2025-11-18

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT06038032. Inclusion in this directory is not an endorsement.