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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
90
Working closely with 51 cancer patients, medical and paramedical personnel, we co-designed an intelligent personalized mobile application to first collect ecologically momentary assessment data on symptoms like pain and fatigue and Health-Related Quality of Life and subsequently enhance symptom management of cancer patients at home. The full description is available here: https://dl.acm.org/doi/abs/10.1145/3491101.3503562?casa\_token=tC5fSN8-k5EAAAAA:56\_TMf6HitVQXZypY2j9FCCcroIFZW9kxxzCEt0yJNFJmNrv79m9W7htznSzMWqGLwE4eimBU0vkLA
Cyprus University of Technology
Limassol, Cyprus
Change in usability and feasibility from baseline to one week later
System Usability and Feasibility questionnaire
Time frame: Baseline, after treatment (1 week later)
EORTC QLQ-C-30
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)
Time frame: Baseline, after treatment (1 week later)
Fatigue Assessment Scale (FAS)
Fatigue Assessment Scale with one score (minimum 10 maximum 50) with higher scores indicating worse outcome (higher fatigue)
Time frame: Baseline, after treatment (1 week later)
Depression using DASS-21
DASS-21 depression scale with cut off scores: 0-9 normal, 10-13 mild, 14-20 moderate, 21-27 severe and 28+ extremely severe
Time frame: Baseline, after treatment (1 week later)
Anxiety using DASS-21
DASS-21 anxiety scale with cut off scores: 0-7 normal, 8-9 mild, 10-14 moderate, 15-19 severe and 20+ extremely severe
Time frame: Baseline, after treatment (1 week later)
Stress using DASS-21
DASS-21 stress scale with cut off scores: 0-14 normal, 15-18 mild, 19-25 moderate, 26-33 severe and 34+ extremely severe
Time frame: Baseline, after treatment (1 week later)
Functionality using EQ-5D-5L
EQ-5D-5L score is from 0-100 with higher scores indicating better outcome (higher functionality)
Time frame: Baseline, after treatment (1 week later)
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