Improving health behaviors for life after endometrial cancer

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

This study tests whether a 24-week online wellness program with expert support can help endometrial cancer survivors improve their health habits like eating better, being more active, and practicing mindfulness.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Alberta (other)
• Locations: 2 sites (Edmonton, Alberta and 1 other locations)
• Trial ID: NCT06038032 on ClinicalTrials.gov

What this trial studies

This trial evaluates a 24-week program that utilizes a digital wellness platform combined with online support from healthcare professionals to improve health outcomes in endometrial cancer survivors. Participants will be randomly assigned to either an intervention group, which engages with the platform and expert guidance, or a control group that receives standard health information initially. The study aims to enhance nutrition, physical activity, and mindfulness practices among participants, addressing the increased risk of cardiac complications post-treatment. All participants will also use an activity tracker to monitor their physical activity levels.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of low-grade, early-stage endometrial cancer, who are within 1 month to 10 years post-surgery and have a BMI between 25 and 45 kg/m2.

Not a fit: Patients with recurrent or metastatic disease, significant weight fluctuations, or those with uncontrolled chronic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve the health and quality of life for endometrial cancer survivors by promoting healthier lifestyle choices.

How similar studies have performed: Other studies have shown promise in using digital health interventions for cancer survivors, suggesting potential success for this approach.

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/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 limitations impacting ability to perform physical activity.
* Self-report following a structured hypocaloric diet (e.g., using formulated meal replacements, weight loss meal program) or a restrictive diet (intermittent fasting, or high-fat diet) in the past three months, or self-report currently following a vegan diet but for less than two years.
* Self-reported history of an eating disorder diagnosed by a physician.
* Intending to be away longer than 2 weeks consecutively during the intervention and unable to adhere to the study protocol during this period.
* Active substance abuse (alcohol, cannabis, illicit drugs, prescription drugs).
* Dual-energy x-ray absorptiometry (DXA) or magnetic resonance imaging (MRI) contraindications for research purposes, such as pacemakers or pregnancy
* Unable to participate in telephone and virtual intervention protocols (e.g., having a severe hearing or vision loss).
* Unable to adhere to the study protocol (i.e., unavailable to commit to scheduled group video conferencing sessions; limited access to the Internet; not willing to use platform, individuals who have been advised by a health professional not to lose weight or reduce caloric intake; cognitive impairment or dementia; etc.).
* Unable to come to study location.
* Unable to provide written informed consent.

Where this trial is running

Edmonton, Alberta and 1 other locations

• University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
• University of Toronto — Toronto, Canada (RECRUITING)

Study contacts

• Principal investigator: Carla Prado, PhD — University of Alberta
• Study coordinator: Teresita Gormaz, MSc

Conditions: Endometrial Cancer