Clinical trial NCT05911672: Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer Care Using Innovative Approaches
Official title: Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer CarE Using Innovative Approaches: The ePROM Digital Health Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: cancer
digital health
Ecologically Momentary Assessment
Ecologically Momentary Intervention
Virtual Reality
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: German Oncology Center, Cyprus
name: CYENS Centre of Excellence
First posted: 2023-06-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomized into three groups: Full Intervention; Partial Intervention and Control
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in usability and feasibility from baseline to one week later
timeFrame: Baseline, after treatment (1 week later)
Secondary outcomes:
measure: EORTC QLQ-C-30
timeFrame: Baseline, after treatment (1 week later)
measure: Fatigue Assessment Scale (FAS)
timeFrame: Baseline, after treatment (1 week later)
measure: Depression using DASS-21
timeFrame: Baseline, after treatment (1 week later)
measure: Anxiety using DASS-21
timeFrame: Baseline, after treatment (1 week later)
measure: Stress using DASS-21
timeFrame: Baseline, after treatment (1 week later)
measure: Functionality using EQ-5D-5L
timeFrame: Baseline, after treatment (1 week later)
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Cyprus University of Technology
Study officials:
References: