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| ID | Type | Description | Link |
|---|---|---|---|
| OPPORTUNITY/0916/ MSCA/0016 | Other Identifier | Cyprus Research and Innovation Foundation |
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| Name | Class |
|---|---|
| German Oncology Center, Cyprus | OTHER |
| CYENS Centre of Excellence | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Intervention | Experimental | 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 |
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| Partial Intervention | Active Comparator | 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. |
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| Control | No Intervention | This group will receive the EMA but no the EMI. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRICE | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in usability and feasibility from baseline to one week later | System Usability and Feasibility questionnaire | Baseline, after treatment (1 week later) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Fatigue Assessment Scale (FAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angelos Kassianos, PhD | Contact | 0035725002252 | angelos.kassianos@cut.ac.cy |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cyprus University of Technology | Limassol | Cyprus |
Individual participant data will be available in Open Science Framework (OSF) and to anyone with reasonable request per Open Science principles.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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patients will be randomized into three groups: Full Intervention; Partial Intervention and Control
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Patients and providers (nurses and clinicians) will be blinded on the type of intervention received.
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Fatigue Assessment Scale with one score (minimum 10 maximum 50) with higher scores indicating worse outcome (higher fatigue) |
| Baseline, after treatment (1 week later) |
| 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) |
| 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) |
| 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) |
| 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) |