Clinical trial · Interventional
ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial
The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.
NCT06038032CI-TRIAL-00097457RESILIENCErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital wellness platform | Behavioral | — | UNRESOLVED |
| Online healthcare professional support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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.
- interventionNames
- Behavioral: Digital wellness platform
- Behavioral: Online healthcare professional support
- type
- NO_INTERVENTION
- label
- Control group
- description
- 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.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. * 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. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.