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Clinical Trials/NCT05911672
NCT05911672
Not Yet Recruiting
N/A

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

Cyprus University of Technology1 site in 1 country90 target enrollmentJune 20, 2023
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
Cyprus University of Technology
Enrollment
90
Locations
1
Primary Endpoint
Change in usability and feasibility from baseline to one week later
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2023
End Date
June 20, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angelos Kassianos

Lecturer

Cyprus University of Technology

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with any type of cancer
  • Treated as either inpatient or outpatient
  • Good understanding of Greek
  • Able to consent
  • No psychiatric comorbidities

Exclusion Criteria

  • Diagnosed with psychiatric disorders
  • Unable to consent

Outcomes

Primary Outcomes

Change in usability and feasibility from baseline to one week later

Time Frame: Baseline, after treatment (1 week later)

System Usability and Feasibility questionnaire

Secondary Outcomes

  • 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))

Study Sites (1)

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