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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital wellness platform | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and week 24 |
| Change from baseline in body weight (in kg) at weeks 16 and 24. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresita Gormaz, MSc | Contact | 780-492-1151 | resilience.trial@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Carla Prado, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Recruiting | Edmonton | Alberta | T6G 2E1 | Canada |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Online healthcare professional support | Behavioral | Individual sessions with a registered dietitian, an exercise professional, and a mental health therapist for 16 weeks. |
|
Weight will be measured in kilograms (kg) in triplicate following standardized procedures; average values will be used for analysis. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | Baseline and week 24 |
| University of Toronto | Recruiting | Toronto | Canada |
|
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |