CancerPRICENCT05911672
Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer Care Using Innovative Approaches
A study testing PRICE in people with Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer
- What is being tested?
- PRICE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCyprus
- Study dates
- 20 Jun 2023to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with any type of cancer
- Treated as either inpatient or outpatient
- Good understanding of Greek
- Able to consent
- No psychiatric comorbidities
Who cannot join
- Diagnosed with psychiatric disorders
- Unable to consent
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Cyprus University of Technology
Limassol
Angelos Kassianos, PhD, 0035725002252 ext. 2252, angelos.kassianos@cut.ac.cy
Andri Georgiou, MSc, antri_geor3@hotmail.com
About this study
Official title: Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer CarE Using Innovative Approaches: The ePROM Digital Health Tool
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
- Cancer
- Being tested
- PRICE
- Keywords
- cancer, digital health, Ecologically Momentary Assessment, Ecologically Momentary Intervention, Virtual Reality
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRICEDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: PRICE |
| 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. Receives: Device: PRICE |
| Control | No intervention | This group will receive the EMA but no the EMI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in usability and feasibility from baseline to one week later
System Usability and Feasibility questionnaire
Measured: Baseline, after treatment (1 week later)
Secondary outcomes (6)
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)
Measured: Baseline, after treatment (1 week later)
Fatigue Assessment Scale (FAS)
Fatigue Assessment Scale with one score (minimum 10 maximum 50) with higher scores indicating worse outcome (higher fatigue)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline, after treatment (1 week later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start20 Jun 2023 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomized into three groups: Full Intervention; Partial Intervention and Control
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- German Oncology Center, Cyprus, CYENS Centre of Excellence
- Responsible party
- Principal investigator, Angelos Kassianos, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911672
- Sponsor's protocol ID
- CUT_DN_03
- Other IDs
- OPPORTUNITY/0916/ MSCA/0016
- Acronym
- PRICE
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be available in Open Science Framework (OSF) and to anyone with reasonable request per Open Science principles.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer CarE Using Innovative Approaches: The ePROM Digital Health Tool
- ClinicalTrials.gov ID
- NCT05911672
- Acronym / sponsor ID
- PRICE / CUT_DN_03
- Conditions
- Cancer
- Keywords
- cancer, digital health, Ecologically Momentary Assessment, Ecologically Momentary Intervention, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Collaborators
- German Oncology Center, Cyprus, CYENS Centre of Excellence
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- patients will be randomized into three groups: Full Intervention; Partial Intervention and Control
| Arm | Type | Receives |
|---|---|---|
| Full Intervention | Experimental | Device: PRICEThis 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 |
| Partial Intervention | Active comparator | Device: PRICEThis group will receive the EMA app and the EMI but they will not be prompted to use the EMI according to their EMA data. |
| Control | No intervention | –This group will receive the EMA but no the EMI. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with any type of cancer
- Treated as either inpatient or outpatient
- Good understanding of Greek
- Able to consent
- No psychiatric comorbidities
Key exclusion criteria (2 listed)
- Diagnosed with psychiatric disorders
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRICEWorking 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 | Device | Full Intervention, Partial Intervention |
Primary outcome
Change in usability and feasibility from baseline to one week later
Time frame: Baseline, after treatment (1 week later)
System Usability and Feasibility questionnaire
6 secondary outcomes
EORTC QLQ-C-30
Time frame: Baseline, after treatment (1 week later)
Fatigue Assessment Scale (FAS)
Time frame: Baseline, after treatment (1 week later)
Depression using DASS-21
Time frame: Baseline, after treatment (1 week later)
Anxiety using DASS-21
Time frame: Baseline, after treatment (1 week later)
Stress using DASS-21
Time frame: Baseline, after treatment (1 week later)
Functionality using EQ-5D-5L
Time frame: Baseline, after treatment (1 week later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRICE in people with Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelos Kassianos, PhD (0035725002252, angelos.kassianos@cut.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in usability and feasibility from baseline to one week later (time frame: Baseline, after treatment (1 week later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.