跳至主要内容
临床试验/NCT05911672
NCT05911672尚未招募不适用

Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer CarE Using Innovative Approaches: The ePROM Digital Health Tool

Cyprus University of Technology1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年6月20日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angelos Kassianos

Lecturer

Cyprus University of Technology

研究点 (1)

Loading locations...

相似试验