Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer CarE Using Innovative Approaches: The ePROM Digital Health Tool
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in usability and feasibility from baseline to one week later
研究概览
简要总结
Patient Reported Outcome Measures (PROMs) are patients' reports of their symptom experience, quality of life and functionality. These measures are used as an endpoint to clinical trials but rarely integrated into routine cancer care. Moreover, they are resource intensive and prone to retrospective biases. PRICE project aims to develop and evaluate a digital health tool (ePROM), collecting PROMs at the clinic and additional Ecological Momentary Assessment (EMA) of PROMs using a mobile application. In addition it tests whether patients who are identified to have elevated pain, fatigue, and stress will benefit from an Ecological Momentary Intervention (EMI) based on Virtual Reality environments. EMA can overcome biases and barriers in PROM assessment whilst EMI can offer an easy and possibly cost-effective intervention until patients re-visit the clinic. The project can contribute to monitoring patient data and achieve viable health systems. It is also timely since digital health tools are considered the future of oncology care but often lack robustness in development and evaluation. Patients treated for cancer at the German Oncology Centre in Cyprus will be randomized into three conditions: (a) Full Intervention (patients who are prompted to use the EMI based on their EMA data; (b) Partial Intervention (patients who are prompted to use the EMI irrespective of their EMA data); (c) Control (patients who only provide their EMA without an EMI). A dissemination strategy will ensure findings and innovation are available to the public, clinicians, students and policy-makers.
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
- Double (Participant, Care Provider)
盲法说明
Patients and providers (nurses and clinicians) will be blinded on the type of intervention received.
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with any type of cancer
- •Treated as either inpatient or outpatient
- •Good understanding of Greek
- •Able to consent
- •No psychiatric comorbidities
排除标准
- •Diagnosed with psychiatric disorders
- •Unable to consent
结局指标
主要结局
Change in usability and feasibility from baseline to one week later
时间窗: Baseline, after treatment (1 week later)
System Usability and Feasibility questionnaire
次要结局
- Anxiety using DASS-21(Baseline, after treatment (1 week later))
- EORTC QLQ-C-30(Baseline, after treatment (1 week later))
- Functionality using EQ-5D-5L(Baseline, after treatment (1 week later))
- Fatigue Assessment Scale (FAS)(Baseline, after treatment (1 week later))
- Depression using DASS-21(Baseline, after treatment (1 week later))
- Stress using DASS-21(Baseline, after treatment (1 week later))
研究者
Angelos Kassianos
Lecturer
Cyprus University of Technology
