ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial

Endometrial Cancer Clinical Trial

— RESILIENCE  

Official title:

The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038032
• Other study ID #: HREBA.CC-23-0209
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: March 2028

Study information

• Verified date: May 2024
• Source: University of Alberta
• Contact: Teresita Gormaz, MSc
• Phone: 780-492-1151
• Email: resilience.trial[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old

• History of endometrial cancer (low-grade, early stage).

• 1 month to 5 years post-surgery and completion of adjuvant treatment.

• BMI =30 and =45 kg/m2.

• Able to speak, read and understand English.

Exclusion Criteria:

• Recurrent or metastatic disease.

• Weight fluctuations (±5 kg) within the previous 3 months.

• Type 1 diabetes; uncontrolled thyroid disorder or type 2 diabetes.

• Taking medications that may alter energy metabolism, body weight and composition.

• 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, or physical or mobility limitations impacting ability to perform physical activity.

• Self-report following a structured hypocaloric or a restrictive diet in the past three months, or self-report currently following a vegan diet but for no more than two years.

• Self-reported history of an eating disorder diagnosed by a physician.

• Contraindications for imaging tests, such as pacemakers, pregnancy, and magnetic implants.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Behavioral:
• Digital wellness platform
A 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.
• Online healthcare professional support
Individual and group sessions with a registered dietitian, an exercise professional, and a mental health therapist for 16 weeks.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	University of Toronto	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in waist circumference at 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.	Baseline to week 16
Secondary	Change from baseline in waist circumference at week 24.	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.	Baseline and week 24
Secondary	Change from baseline in body weight (in kg) at weeks 16 and 24.	Weight will be measured in kilograms (kg) in triplicate following standardized procedures; average values will be used for analysis.	Baseline, week 16, and week 24
Secondary	Change from baseline in fat mass by DXA at weeks 16 and 24.	Percentage fat mass will be measured using dual-energy x-ray absorptiometry (DXA), which is a precise and reliable technique.	Baseline, week 16, and week 24
Secondary	Change from baseline in appendicular lean soft tissue by DXA at weeks 16 and 24.	Appendicular lean soft tissue will be measured using dual-energy x-ray absorptiometry (DXA), which is a precise and reliable technique. Appendicular lean soft tissue will be adjusted for body weight.	Baseline, week 16, and week 24
Secondary	Change from baseline in metabolic syndrome by Z score calculation at weeks 16 and 24.	Metabolic syndrome severity Z score will be calculated using waist circumference, blood pressure, high-density lipoprotein cholesterol, triglycerides, and fasting glucose data in sex- and ethnicity-specific equations.	Baseline, week 16, and week 24
Secondary	Change from baseline in cardiovascular risk based on the Framingham risk score at weeks 16 and 24.	10-year cardiovascular risk will be estimated using sex-specific Framingham risk score based on traditional risk factors. Risk is low if the score is less than 10% and high if it is 20% or higher.	Baseline, week 16, and week 24
Secondary	Change from baseline in handgrip muscle strength at weeks 16 and 24.	Handgrip strength will be evaluated using a hydraulic handgrip dynamometer.	Baseline, week 16, and week 24
Secondary	Change from baseline in cardiorespiratory fitness by a cardiopulmonary exercise testing (CPET) at weeks 16 and 24.	Peak oxygen uptake will be measured by gold standard cardiopulmonary exercise testing.	Baseline, week 16, and week 24
Secondary	Change from baseline in health-related life improvement by the QLQ-C30 at weeks 16 and 24.	Participants will complete the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30). Score ranges from 0 to 100. Higher scores on symptoms and single-items indicate a higher level of symptoms.	Baseline, week 16, and week 24
Secondary	Change from baseline in health-related life improvement by the QLQ-EN24 at weeks 16 and 24.	Participants will complete the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire -Endometrial Cancer Module (EORTC QLQ-EN24). Score ranges from 0 to 100. Higher scores on symptoms and single-items indicate a higher level of symptoms.	Baseline, week 16, and week 24
Secondary	Change from baseline in carotid intima-media thickness by ultrasound at weeks 16 and 24.	Carotid intima-media thickness will be assessed by a B-mode ultrasound following a standardized protocol.	Baseline, week 16, and week 24
Secondary	Change from baseline in abdominal adiposity by MRI at week 24.	Abdominal adipose tissue will be measure using magnetic resonance imaging (MRI).	Baseline and week 24
Secondary	Change from baseline in abdominal skeletal muscle by MRI at week 24.	Abdominal skeletal muscle will be measure using magnetic resonance imaging (MRI).	Baseline and week 24
Secondary	Change from baseline in adipose tissue in liver by MRI at week 24.	Adipose tissue in liver will be measure using magnetic resonance imaging (MRI).	Baseline and week 24
Secondary	Change from baseline in adipose tissue in the thigh region by MRI at week 24.	Adipose tissue in the thigh region will be measure using magnetic resonance imaging (MRI).	Baseline and week 24
Secondary	Change from baseline in skeletal muscle in the thigh region by MRI at week 24.	Skeletal muscle in the thigh region will be measure using magnetic resonance imaging (MRI).	Baseline and week 24
Secondary	Change from baseline in cardiac function by MRI at week 24.	Cardiac function will be measure using magnetic resonance imaging (MRI).	Baseline and week 24