The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• ≥ 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.
Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
University of Toronto
RECRUITING
Toronto
Contact Information
Primary
Teresita Gormaz, MSc
resilience.trial@ualberta.ca
780-492-1151
Time Frame
Start Date:2024-03-25
Estimated Completion Date:2028-03
Participants
Target number of participants:148
Treatments
Experimental: Intervention group
Participants will receive the intervention for 24 weeks. The first 16 weeks will involve an intensive behavioral program (digital wellness platform plus online healthcare professional support), followed by an 8-week maintenance period (digital wellness platform alone).~At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.
No_intervention: Control group
At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.