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

Cyprus University of Technology

Status: Not yet enrolling

Conditions: Cancer

Treatments: Device: PRICE

Study type: Interventional

Funder types: Other

Identifiers

NCT05911672

OPPORTUNITY/0916/ MSCA/0016 (Other Identifier)

CUT_DN_03

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Full Intervention

Experimental group

Description:

This group will receive the app (PRICE) which will collect their PROMs (pain, fatigue and stress) three times a day for 2 weeks. They will be prompted each time they have elevated levels of pain, fatigue and stress to use the VR glasses (EMI). This is the EMI provided: https://dl.acm.org/doi/abs/10.1145/3491101.3503562?casa_token=tC5fSN8-k5EAAAAA:56_TMf6HitVQXZypY2j9FCCcroIFZW9kxxzCEt0yJNFJmNrv79m9W7htznSzMWqGLwE4eimBU0vkLA

Treatment:

Device: PRICE

Partial Intervention

Active Comparator group

Description:

This group will receive the EMA app and the EMI but they will not be prompted to use the EMI according to their EMA data.

Treatment:

Device: PRICE

Control

No Intervention group

Description:

This group will receive the EMA but no the EMI.