Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer Care Using Innovative Approaches

Not Applicable

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT05911672
• Lead Sponsor: Cyprus University of Technology

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-08
• Study Start: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Last Update Submitted: 2023-06-20
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2023-12-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in usability and feasibility from baseline to one week later	Baseline, after treatment (1 week later)	System Usability and Feasibility questionnaire

Secondary Outcome Measures

Name	Time	Method
Anxiety using DASS-21	Baseline, after treatment (1 week later)	DASS-21 anxiety scale with cut off scores: 0-7 normal, 8-9 mild, 10-14 moderate, 15-19 severe and 20+ extremely severe
EORTC QLQ-C-30	Baseline, after treatment (1 week later)	Health-Related Quality of Life. Using the global quality of life scale (minimum 0, maximum 100), with higher scores indicating better outcome (higher quality of life)
Functionality using EQ-5D-5L	Baseline, after treatment (1 week later)	EQ-5D-5L score is from 0-100 with higher scores indicating better outcome (higher functionality)
Fatigue Assessment Scale (FAS)	Baseline, after treatment (1 week later)	Fatigue Assessment Scale with one score (minimum 10 maximum 50) with higher scores indicating worse outcome (higher fatigue)
Depression using DASS-21	Baseline, after treatment (1 week later)	DASS-21 depression scale with cut off scores: 0-9 normal, 10-13 mild, 14-20 moderate, 21-27 severe and 28+ extremely severe
Stress using DASS-21	Baseline, after treatment (1 week later)	DASS-21 stress scale with cut off scores: 0-14 normal, 15-18 mild, 19-25 moderate, 26-33 severe and 34+ extremely severe

Trial Locations

Locations (1)

Cyprus University of Technology; 🇨🇾 Limassol, Cyprus