Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-28 @ 7:04 AM
Study NCT ID:
NCT06038032
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2023-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in waist circumference at week 16.', 'timeFrame': 'Baseline to week 16', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in waist circumference at week 24.', 'timeFrame': 'Baseline and week 24', 'description': '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.'}, {'measure': 'Change from baseline in body weight (in kg) at weeks 16 and 24.', 'timeFrame': 'Baseline, week 16, and week 24', 'description': 'Weight will be measured in kilograms (kg) in triplicate following standardized procedures; average values will be used for analysis.'}, {'measure': 'Change from baseline in fat mass by DXA at weeks 16 and 24.', 'timeFrame': 'Baseline, week 16, and week 24', 'description': 'Percentage fat mass will be measured using dual-energy x-ray absorptiometry (DXA), which is a precise and reliable technique.'}, {'measure': 'Change from baseline in appendicular lean soft tissue by DXA at weeks 16 and 24.', 'timeFrame': 'Baseline, week 16, and week 24', 'description': '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.'}, {'measure': 'Change from baseline in metabolic syndrome by Z score calculation at weeks 16 and 24.', 'timeFrame': 'Baseline, week 16, and week 24', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'Change from baseline in handgrip muscle strength at weeks 16 and 24.', 'timeFrame': 'Baseline, week 16, and week 24', 'description': 'Handgrip strength will be evaluated using a hydraulic handgrip dynamometer.'}, {'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', 'description': 'Peak oxygen uptake will be measured by gold standard cardiopulmonary exercise testing.'}, {'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', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'Change from baseline in carotid intima-media thickness by ultrasound at weeks 16 and 24.', 'timeFrame': 'Baseline, week 16, and week 24', 'description': 'Carotid intima-media thickness will be assessed by a B-mode ultrasound following a standardized protocol.'}, {'measure': 'Change from baseline in abdominal adiposity by MRI at week 24.', 'timeFrame': 'Baseline and week 24', 'description': 'Abdominal adipose tissue will be measure using magnetic resonance imaging (MRI).'}, {'measure': 'Change from baseline in abdominal skeletal muscle by MRI at week 24.', 'timeFrame': 'Baseline and week 24', 'description': 'Abdominal skeletal muscle will be measure using magnetic resonance imaging (MRI).'}, {'measure': 'Change from baseline in adipose tissue in liver by MRI at week 24.', 'timeFrame': 'Baseline and week 24', 'description': 'Adipose tissue in liver will be measure using magnetic resonance imaging (MRI).'}, {'measure': 'Change from baseline in adipose tissue in the thigh region by MRI at week 24.', 'timeFrame': 'Baseline and week 24', 'description': 'Adipose tissue in the thigh region will be measure using magnetic resonance imaging (MRI).'}, {'measure': 'Change from baseline in skeletal muscle in the thigh region by MRI at week 24.', 'timeFrame': 'Baseline and week 24', 'description': 'Skeletal muscle in the thigh region will be measure using magnetic resonance imaging (MRI).'}, {'measure': 'Change from baseline in cardiac function by MRI at week 24.', 'timeFrame': 'Baseline and week 24', 'description': 'Cardiac function will be measure using magnetic resonance imaging (MRI).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nObjective: 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.\n\nStudy Design:\n\nGroup 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.\n\nGroup 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.\n\nCommon 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 18 years old\n* Histologically confirmed endometrioid adenocarcinoma (low-grade), FIGO 2009 stages I to III.\n* 1 month to 10 years post-surgery and completion of adjuvant treatment.\n* BMI ≥25 and ≤45 kg/m2.\n* Willing and able to adhere to the study interventions and assessments\n* Seeking best weight using the readiness to change questionnaire.\n* Have a cell phone compatible with the Fitbit app with internet access and Bluetooth capabilities.\n* Able to speak, read and understand English.\n\nExclusion Criteria:\n\n* Recurrent (local, regional, or distant) or metastatic EC.\n* Abnormal (i.e., mutated) p53 status in combination with FIGO 2009 stage III or IV\n* Weight fluctuations (±5 kg) within the previous 3 months.\n* Planned surgery in the next 6 months.\n* Previous bariatric surgery.\n* Uncontrolled thyroid disorder\n* Type 1 diabetes.\n* Type 2 diabetes with HbA1c \\> 10% or are taking insulin, sulfonylureas, or GLP-1 agonists.\n* Taking corticosteroids.\n* Taking anti-obesity drugs.\n* Current smoker (of any type, e.g e-cigarettes, tobacco, marihuana, vaping)\n* Self-report \\>90 moderate-intensity min/week of aerobic physical activity on average over the past three months.\n* 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.\n* Physical or mobility limitations impacting ability to perform physical activity.\n* 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.\n* Self-reported history of an eating disorder diagnosed by a physician.\n* Intending to be away longer than 2 weeks consecutively during the intervention and unable to adhere to the study protocol during this period.\n* Active substance abuse (alcohol, cannabis, illicit drugs, prescription drugs).\n* Dual-energy x-ray absorptiometry (DXA) or magnetic resonance imaging (MRI) contraindications for research purposes, such as pacemakers or pregnancy\n* Unable to participate in telephone and virtual intervention protocols (e.g., having a severe hearing or vision loss).\n* 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.).\n* Unable to come to study location.\n* Unable to provide written informed consent."}, 'identificationModule': {'nctId': 'NCT06038032', 'acronym': 'RESILIENCE', 'briefTitle': 'ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.', 'orgStudyIdInfo': {'id': 'HREBA.CC-23-0209'}}, 'armsInterventionsModule': {'armGroups': [{'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).\n\nAt 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.'}], 'interventions': [{'name': 'Digital wellness platform', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention group']}, {'name': 'Online healthcare professional support', 'type': 'BEHAVIORAL', 'description': 'Individual sessions with a registered dietitian, an exercise professional, and a mental health therapist for 16 weeks.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2E1', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Carla Prado, PI', 'role': 'CONTACT', 'email': 'carla.prado@ualberta.ca', 'phone': '7804927934'}, {'name': 'Teresita Gormaz, MSc', 'role': 'CONTACT', 'email': 'gormazre@ualberta.ca', 'phone': '7804927820'}], 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Toronto', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Amy A Kirkham, PhD', 'role': 'CONTACT', 'email': 'amy.kirkham@utoronto.ca', 'phone': '416-946-4069'}, {'name': 'Amy A Kirkham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Teresita Gormaz, MSc', 'role': 'CONTACT', 'email': 'resilience.trial@ualberta.ca', 'phone': '780-492-1151'}], 'overallOfficials': [{'name': 'Carla Prado, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}