Randomized Controlled Trial of a Mobile App for Remote Patient Monitoring in Oncology: a Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 主要终点
- feasibility and usability of the MHapp
研究概览
简要总结
With the growing number of cancer survivors, challenges to deal with comorbidities and impacted quality of life of cancer survivors by the disease and treatments also surge. Symptoms and Adverse Events are common and insufficiently monitored in real time / real life, which leads to increased symptom burden, treatment delays and unplanned hospital admissions. Remote monitoring apps have been shown to improve quality of life, symptom control and survival in published clinical trials, but no data with such interventions exists on the Portuguese population.
A phase II randomized controlled trial to explore the feasibility of a mobile app for remote symptom monitoring in cancer patients will be done. Patients will be recruited in Portuguese Hospitals and will be invited to test the app for three months. Patient experience and satisfaction will be assessed via a weekly survey. Quality of life will be assessed at 1 and 3 months.
The results of this pilot study will inform subsequent randomized clinical trials to test safety and efficacy of remote monitoring and lifestyle interventions to improve symptoms control and quality of life.
详细描述
The primary aim is to assess the feasibility and usability of a mobile app (MHapp) to remote register and monitor treatment side effects, lifestyle habits and clinical data in cancer patients.
This is a phase II randomized controlled trial with two study arms:
Arm MH - mobile Mentora app to monitor and track treatment side-effects, vital signs, therapeutics and daily habits; Arm C - SOC
No sham intervention is thought to be viable as we want to test the MHapp as a whole complex intervention with all different components and compare it with current SOC. Patients will be screened at oncology visits for inclusion criteria. It is not viable also to blind clinicians once the app provides a detailed progress report of which we want to assess the impact on oncology care and clinical team satisfaction. We will blind statisticians and people performing the final analysis.
Once agreeing to enrol, patients will be randomly allocated to one of the study arms through a computer generated sequence of numbers, concealed from the clinical staff and patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (18 years old or older)
- •with a cancer diagnosis at any stage
- •Receiving systemic chemotherapy not in the context of a clinical trial, with treatment
- •expected to continue for at least three months counting from time of enrollment
- •fluent in written Portuguese
- •with a personal mobile smartphone (android or iphone any version)
- •willing to give informed consent for study participation
排除标准
- •Cognitive impairment or disability that limits capacity to comply with study interventions and assessments
- •Having a life expectancy < 3 months as determined by the attending oncologist
- •ECOG performance status greater than 2
- •Unable to read and comprehend portuguese language text
结局指标
主要结局
feasibility and usability of the MHapp
时间窗: 1 month
The outcome will be considered positive if at least one of the 2 following criteria applies to more than 60 percent of participants enrolled: replies to 2 or more weekly reports OR at least one weekly log in to the app.
次要结局
- To evaluate the impact of MHapp on cancer patients QoL on European Organisation for Research and Treatment of Cancer.(EORTC) Core (c)30(1 and 3 months)
- To understand how to improve users' experience navigating the MHapp(1 week, 1 month, 3 months)
- To explore the satisfaction of cancer patients, clinical teams and their carers with the MHapp(1 week, 1 month, 3 months)
- To compare healthcare resources use in both study arms(1 month, 3 months)
- To report adherence rates to the app usage at 1 and 3 months on the intervention arm(1 month, 3 months)
- To evaluate the impact on AEs G>2 per CTCAE (Common Terminology Criteria for Adverse Events) v.5 (minimum 1 maximum 4)(1 and 3 months)