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

NCT ID: NCT05911672

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-06-20

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Full Intervention

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

Group Type: EXPERIMENTAL

PRICE

Intervention Type: 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

Partial Intervention

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.

Group Type: ACTIVE_COMPARATOR

PRICE

Intervention Type: 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

Control

This group will receive the EMA but no the EMI.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PRICE

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Oncology Center, Cyprus

OTHER

Sponsor Role: collaborator

CYENS Centre of Excellence

UNKNOWN

Sponsor Role: collaborator

Cyprus University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Angelos Kassianos

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cyprus University of Technology

Limassol, , Cyprus

Countries

Cyprus

Central Contacts

Angelos Kassianos, PhD

Role: CONTACT

angelos.kassianos@cut.ac.cy

0035725002252

Facility Contacts

Angelos Kassianos, PhD

Role: primary

angelos.kassianos@cut.ac.cy

0035725002252 ext. 2252

Andri Georgiou, MSc

Role: backup

antri_geor3@hotmail.com

Other Identifiers

OPPORTUNITY/0916/ MSCA/0016

Identifier Type: OTHER

Identifier Source: secondary_id

CUT_DN_03

Identifier Type: -

Identifier Source: org_study_id