Cancer
Conditions
Keywords
cancer, digital health, Ecologically Momentary Assessment, Ecologically Momentary Intervention, Virtual Reality
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.
Interventions
DEVICEPRICE
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
Sponsors
German Oncology Center, Cyprus
CYENS Centre of Excellence
Cyprus University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients and providers (nurses and clinicians) will be blinded on the type of intervention received.
Intervention model description
patients will be randomized into three groups: Full Intervention; Partial Intervention and Control
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in usability and feasibility from baseline to one week later | Baseline, after treatment (1 week later) | System Usability and Feasibility questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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 |
| 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) |
Countries
Cyprus
Contacts
Primary ContactAngelos Kassianos, PhD
Outcome results
None listed