Endometrial CancerRESILIENCENCT06038032
ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial
A study testing Digital wellness platform and Online healthcare professional support in people with Endometrial Cancer, run by University of Alberta at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Digital wellness platform and Online healthcare professional support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Mar 2024to Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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.
- Self-reported BMI ≥25 and ≤45 kg/m2, or self-reported BMI ≥18.5 and ≤24.9 kg/m2 together with a cardiometabolic condition or waist circumference ≥80 cm. Cardiometabolic conditions are also self-reported and included type 2 diabetes, prediabetes, hypertension, dyslipidemia, coronary artery disease, and stroke among others.
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2E1
Carla Prado, PI, 7804927934, carla.prado@ualberta.ca
Teresita Gormaz, MSc, 7804927820, gormazre@ualberta.ca
- Recruiting
University of Toronto
Toronto
Amy A Kirkham, PhD, 416-946-4069, amy.kirkham@utoronto.ca
Amy A Kirkham, PhD
About this study
Official title: The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.
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.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- Digital wellness platform, Online healthcare professional support
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital wellness platformBehavioural
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 supportBehavioural
Individual sessions with a registered dietitian, an exercise professional, and a mental health therapist for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive the intervention for 24 weeks. The first 16 weeks will involve an intensive behavioral program (digital wellness platform plus online healthcare professional support), followed by an 8-week maintenance period (digital wellness platform alone).
At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks. Receives: Behavioral: Digital wellness platform; Behavioral: Online healthcare professional support |
| Control group | No intervention | At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week 16
Secondary outcomes (17)
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.
Measured: Baseline and week 24
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.
Measured: Baseline, week 16, and week 24
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.
Measured: Baseline, week 16, and week 24
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.
Measured: Baseline, week 16, and week 24
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.
Measured: Baseline, week 16, and week 24
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.
Measured: Baseline, week 16, and week 24
Change from baseline in handgrip muscle strength at weeks 16 and 24.
Handgrip strength will be evaluated using a hydraulic handgrip dynamometer.
Measured: Baseline, week 16, and week 24
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.
Measured: Baseline, week 16, and week 24
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.
Measured: Baseline, week 16, and week 24
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.
Measured: Baseline, week 16, and week 24
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.
Measured: Baseline, week 16, and week 24
Change from baseline in abdominal adiposity by MRI at week 24.
Abdominal adipose tissue will be measure using magnetic resonance imaging (MRI).
Measured: Baseline and week 24
Change from baseline in abdominal skeletal muscle by MRI at week 24.
Abdominal skeletal muscle will be measure using magnetic resonance imaging (MRI).
Measured: Baseline and week 24
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).
Measured: Baseline and week 24
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).
Measured: Baseline and week 24
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).
Measured: Baseline and week 24
Change from baseline in cardiac function by MRI at week 24.
Cardiac function will be measure using magnetic resonance imaging (MRI).
Measured: Baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start25 Mar 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla Prado, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038032
- Sponsor's protocol ID
- HREBA.CC-23-0209
- Acronym
- RESILIENCE
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No