Overview
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.
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.