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

Cancer Clinical Trial

— PRICE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05911672
• Other study ID #: CUT_DN_03
• Secondary ID: OPPORTUNITY/0916
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: June 2023
• Source: Cyprus University of Technology
• Contact: Angelos Kassianos, PhD
• Phone: 0035725002252
• Email: angelos.kassianos[@]cut.ac.cy
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Cyprus	Cyprus University of Technology	Limassol

Sponsors (3)

Lead Sponsor	Collaborator
Cyprus University of Technology	CYENS Centre of Excellence, German Oncology Center, Cyprus

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in usability and feasibility from baseline to one week later	System Usability and Feasibility questionnaire	Baseline, after treatment (1 week later)
Secondary	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)	Baseline, after treatment (1 week later)
Secondary	Fatigue Assessment Scale (FAS)	Fatigue Assessment Scale with one score (minimum 10 maximum 50) with higher scores indicating worse outcome (higher fatigue)	Baseline, after treatment (1 week later)
Secondary	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	Baseline, after treatment (1 week later)
Secondary	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	Baseline, after treatment (1 week later)
Secondary	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	Baseline, after treatment (1 week later)
Secondary	Functionality using EQ-5D-5L	EQ-5D-5L score is from 0-100 with higher scores indicating better outcome (higher functionality)	Baseline, after treatment (1 week later)