NCT05911672

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Cyprus University of Technology · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DEVICE	PRICE	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

Timeline

• Start date: 2023-06-20
• Primary completion: 2023-12-20
• Completion: 2024-06-20
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: Cyprus