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

NCT05911672 | Unknown DMC

• 2 other identifiers: CUT_DN_03OPPORTUNITY/0916/ MSCA/0016
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

cancer; digital health; Ecologically Momentary Assessment; Ecologically Momentary Intervention; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Change in usability and feasibility from baseline to one week later

  System Usability and Feasibility questionnaire

  Baseline, after treatment (1 week later)

Secondary Outcomes (6)

• EORTC QLQ-C-30

  Baseline, after treatment (1 week later)

• Fatigue Assessment Scale (FAS)

  Baseline, after treatment (1 week later)

• Depression using DASS-21

  Baseline, after treatment (1 week later)

• Anxiety using DASS-21

  Baseline, after treatment (1 week later)

• Stress using DASS-21

  Baseline, after treatment (1 week later)

Study Arms (3)

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

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.

Device: PRICE

Control

NO INTERVENTION

This group will receive the EMA but no the EMI.

Interventions

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

Full Intervention; Partial Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with any type of cancer
• Treated as either inpatient or outpatient
• Good understanding of Greek
• Able to consent
• No psychiatric comorbidities

You may not qualify if:

• Diagnosed with psychiatric disorders
• Unable to consent

Sponsors & Collaborators

• Cyprus University of Technology: lead
• German Oncology Center, Cyprus: collaborator
• CYENS Centre of Excellence: collaborator

Study Sites (1)

Cyprus University of Technology

Limassol, Cyprus

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Angelos Kassianos, PhD

CONTACT

0035725002252; angelos.kassianos@cut.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients and providers (nurses and clinicians) will be blinded on the type of intervention received.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: patients will be randomized into three groups: Full Intervention; Partial Intervention and Control

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 22, 2023
• Study Start: June 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: June 20, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CY (1)