Clinical trial NCT06038032: ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial
Official title: The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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 criteria: Inclusion Criteria:

* ≥ 18 years old
* History of endometrial cancer (low-grade, early stage).
* 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 or metastatic disease.
* 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; uncontrolled thyroid disorder or 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, or 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).
* Contraindications for imaging tests, such as pacemakers, pregnancy, and magnetic implants.
* 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.

Primary outcomes:
measure: Change from baseline in waist circumference at week 16.
timeFrame: Baseline to week 16
Secondary outcomes:
measure: Change from baseline in waist circumference at week 24.
timeFrame: Baseline and week 24
measure: Change from baseline in body weight (in kg) at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in fat mass by DXA at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in appendicular lean soft tissue by DXA at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in metabolic syndrome by Z score calculation at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in cardiovascular risk based on the Framingham risk score at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in handgrip muscle strength at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in cardiorespiratory fitness by a cardiopulmonary exercise testing (CPET) at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in health-related life improvement by the QLQ-C30 at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in health-related life improvement by the QLQ-EN24 at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in carotid intima-media thickness by ultrasound at weeks 16 and 24.
timeFrame: Baseline, week 16, and week 24
measure: Change from baseline in abdominal adiposity by MRI at week 24.
timeFrame: Baseline and week 24
measure: Change from baseline in abdominal skeletal muscle by MRI at week 24.
timeFrame: Baseline and week 24
measure: Change from baseline in adipose tissue in liver by MRI at week 24.
timeFrame: Baseline and week 24
measure: Change from baseline in adipose tissue in the thigh region by MRI at week 24.
timeFrame: Baseline and week 24
measure: Change from baseline in skeletal muscle in the thigh region by MRI at week 24.
timeFrame: Baseline and week 24
measure: Change from baseline in cardiac function by MRI at week 24.
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Toronto
country: Canada
facility: University of Toronto
Study officials:
affiliation: University of Alberta
name: Carla Prado, PhD
role: PRINCIPAL_INVESTIGATOR
References: