PATIENT VOICES Integration of Systematic Assessment of Patient Reported Outcomes Within Clinical Oncology Practice
NCT ID: NCT03968718
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
640 participants
INTERVENTIONAL
2019-05-27
2021-12-31
Brief Summary
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Patient Reported Outcomes Measures (PROMs) and in particular electronically assessed PROMS (ePROMS), have been identified as potentially effective tools to systematically gather patient voices. Despite international extensive and growing interest, systematic PROM collection is not widely implemented in routine cancer care, due to barriers at various levels.
The PATIENT VOICES is a project aimed at achieving a stepwise inclusion and integration of PROMs within routine clinical practice at the FONDAZIONE IRCCS ISTITUTO NAZIONALE TUMORI-MILANO. Phase I of the Patient Voices project (pilot and feasibility testing), will be the focus of the present study and its results will be the base for subsequent phases (implementation and impact assessment).
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Detailed Description
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* Assessing the use and attitudes toward PROMs by clinicians in a comprehensive cancer centre.
* Reviewing and compare pre-existing ePROMS assessment systems.
* Developing and pilot testing a flexible system for electronic collection of PROMs.
* Assessing feasibility of ePROM assessment of physical symptoms, psychological distress and patient satisfaction.
* Identifying barriers to and developing strategies for the final implementation and integration of routine ePROMs into the clinical practice.
The project will last 2 years. Longitudinal and cross-sectional studies will be carried out with the aim to evaluate compliance, acceptability, and usability of a routine ePROM assessment system by both patients and clinicians. Participants will be enrolled among patients attending 3 out-patient clinics (physical symptom), 3 inpatient wards (psychological distress) and 5 multidisciplinary teams (patient satisfaction). The Edmonton symptom assessment scale, the Distress Thermometer, and a questionnaire adapted from the Bench-Can and EURACAN projects plus the institutional customer satisfaction survey, will be used in the three studies. Qualitative methods will be used identify patient and clinician related barriers to ePROM assessment and to pinpoint engagement strategies to promote its use in routine cancer care. Semi-structured interviews and focus groups will be carried out.
Quantitative and qualitative studies will respectively enroll 600 and 40 participants.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Systematic ePROMs Assessment
Intervention: The intervention is constituted by a Systematic ePROMs Assessment in routine cancer care in a comprehensive cancer centre.
This will involve preliminary sensitization and training of both clinicians and patients towards the use of ePROMs.
Data filled in by patients through electronic devices will be prompt made available to the clinician during the patient examination.
Systematic ePROMs Assessment
Depending on the care setting, eligible patients will be asked to fill in one of the following e-PROMs assessment:
Edmonton symptom assessment scale (ESAS-r) (outpatients)
Distress Thermometer (inpatients)
An ad hoc questionnaire adapted from the Bench-Can and EURACAN projects plus the institutional customer satisfaction survey (patients followed by multidisciplinary teams)
Interventions
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Systematic ePROMs Assessment
Depending on the care setting, eligible patients will be asked to fill in one of the following e-PROMs assessment:
Edmonton symptom assessment scale (ESAS-r) (outpatients)
Distress Thermometer (inpatients)
An ad hoc questionnaire adapted from the Bench-Can and EURACAN projects plus the institutional customer satisfaction survey (patients followed by multidisciplinary teams)
Eligibility Criteria
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Inclusion Criteria
* a verified cancer diagnosis
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Responsible Party
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Cinzia Brunelli
Principal Investigator
Principal Investigators
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Cinzia Brunelli, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy
Locations
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milan, Italy
Countries
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Central Contacts
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References
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Brunelli C, Alfieri S, Zito E, Spelta M, Arba L, Lombi L, Caselli L, Caraceni A, Borreani C, Roli A, Miceli R, Tine' G, Zecca E, Platania M, Procopio G, Nicolai N, Battaglia L, Lozza L, Shkodra M, Massa G, Loiacono D, Apolone G. Patient Voices: Multimethod Study on the Feasibility of Implementing Electronic Patient-Reported Outcome Measures in a Comprehensive Cancer Center. JMIR Cancer. 2025 Jan 22;11:e56625. doi: 10.2196/56625.
Brunelli C, Borreani C, Caraceni A, Roli A, Bellazzi M, Lombi L, Zito E, Pellegrini C, Spada P, Kaasa S, Foschi AM, Apolone G; PATIENT VOICES study group. PATIENT VOICES, a project for the integration of the systematic assessment of patient reported outcomes and experiences within a comprehensive cancer center: a protocol for a mixed method feasibility study. Health Qual Life Outcomes. 2020 Jul 28;18(1):252. doi: 10.1186/s12955-020-01501-1.
Other Identifiers
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Istitutotumori
Identifier Type: -
Identifier Source: org_study_id
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