ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial

Официальное название

The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Digital wellness platform
  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.
• Поведенческое Online healthcare professional support
  Individual sessions with a registered dietitian, an exercise professional, and a mental health therapist for 16 weeks.

Первичные конечные точки

• Change from baseline in waist circumference at week 16. [Срок оценки: Baseline to week 16]

Вторичные конечные точки (12)

• Change from baseline in waist circumference at week 24. [Срок оценки: Baseline and week 24]
• Change from baseline in body weight (in kg) at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in fat mass by DXA at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in appendicular lean soft tissue by DXA at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in metabolic syndrome by Z score calculation at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in cardiovascular risk based on the Framingham risk score at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in handgrip muscle strength at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in cardiorespiratory fitness by a cardiopulmonary exercise testing (CPET) at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in health-related life improvement by the QLQ-C30 at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in health-related life improvement by the QLQ-EN24 at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in carotid intima-media thickness by ultrasound at weeks 16 and 24. [Срок оценки: Baseline, week 16, and week 24]
• Change from baseline in abdominal adiposity by MRI at week 24. [Срок оценки: Baseline and week 24]

Критерии участия

Критерии включения

• ≥ 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.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 2 центра

• University of Alberta — Edmonton
• University of Toronto — Toronto

Идентификаторы

NCT: NCT06038032 · HREBA.CC-23-0209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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