The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 3
- 主要终点
- Change from baseline in waist circumference at week 16.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥ 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/m
- •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.
排除标准
- •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.
结局指标
主要结局
Change from baseline in waist circumference at week 16.
时间窗: Baseline to 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.
次要结局
- Change from baseline in appendicular lean soft tissue by DXA at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in handgrip muscle strength at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in adipose tissue in liver by MRI at week 24.(Baseline and week 24)
- Change from baseline in cardiorespiratory fitness by a cardiopulmonary exercise testing (CPET) at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in waist circumference at week 24.(Baseline and week 24)
- Change from baseline in carotid intima-media thickness by ultrasound at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in abdominal skeletal muscle by MRI at week 24.(Baseline and week 24)
- Change from baseline in adipose tissue in the thigh region by MRI at week 24.(Baseline and week 24)
- Change from baseline in cardiac function by MRI at week 24.(Baseline and week 24)
- Change from baseline in body weight (in kg) at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in health-related life improvement by the QLQ-C30 at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in fat mass by DXA at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in metabolic syndrome by Z score calculation at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in cardiovascular risk based on the Framingham risk score at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in health-related life improvement by the QLQ-EN24 at weeks 16 and 24.(Baseline, week 16, and week 24)
- Change from baseline in abdominal adiposity by MRI at week 24.(Baseline and week 24)
- Change from baseline in skeletal muscle in the thigh region by MRI at week 24.(Baseline and week 24)