ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial

Last updated: November 14, 2025
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pelvic Cancer

Endometriosis

Endometrial Cancer

Treatment

My Viva Plan (www.myvivaplan.com)

Online healthcare professional support

Digital wellness platform

Clinical Study ID

NCT06038032
HREBA.CC-23-0209
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • ≥ 18 years old

  • Histologically confirmed endometrioid adenocarcinoma (low-grade), FIGO 2009 stages Ito 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 Bluetoothcapabilities.

  • Able to speak, read and understand English.

Exclusion

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-1agonists.

  • 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 averageover 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 ofCVD, and any of the American Heart Association's absolute or relativecontraindications to exercise testing.

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

  • Self-report following a structured hypocaloric diet (e.g., using formulated mealreplacements, weight loss meal program) or a restrictive diet (intermittent fasting,or high-fat diet) in the past three months, or self-report currently following avegan 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 andunable 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., havinga severe hearing or vision loss).

  • Unable to adhere to the study protocol (i.e., unavailable to commit to scheduledgroup video conferencing sessions; limited access to the Internet; not willing touse platform, individuals who have been advised by a health professional not to loseweight or reduce caloric intake; cognitive impairment or dementia; etc.).

  • Unable to come to study location.

  • Unable to provide written informed consent.

Study Design

Total Participants: 148
Treatment Group(s): 3
Primary Treatment: My Viva Plan (www.myvivaplan.com)
Phase:
Study Start date:
March 25, 2024
Estimated Completion Date:
March 31, 2028

Study 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.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G 2E1
    Canada

    Site Not Available

  • University of Alberta

    Edmonton 5946768, Alberta 5883102 T6G 2E1
    Canada

    Active - Recruiting

  • University of Toronto

    Toronto,
    Canada

    Site Not Available

  • University of Toronto

    Toronto 6167865,
    Canada

    Active - Recruiting

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