Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRICE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Full Intervention
- 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
- interventionNames
- Device: PRICE
- type
- ACTIVE_COMPARATOR
- label
- Partial Intervention
- 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.
- interventionNames
- Device: PRICE
- type
- NO_INTERVENTION
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available