Clinical trial · Interventional
PATIENT VOICES Integration of Systematic Assessment of Patient Reported Outcomes Within Clinical Oncology Practice
PATIENT VOICES - A Project for the Integration of Systematic Assessment of Patient Reported Outcomes Within an E-Health Program in an Italian Comprehensive Cancer Center
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Listening to "patient voices" in terms of symptoms, emotional status, satisfaction with care and information received, represents a major shift in medicine. It is in fact crucial in medical decision making and patient empowerment, especially in cancer care. 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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Psychological Distress | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Satisfaction, Consumer | — | UNRESOLVED | — |
| Symptoms and Signs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Systematic ePROMs Assessment | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Systematic ePROMs Assessment
- description
- 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.
- interventionNames
- Behavioral: Systematic ePROMs Assessment
Primary outcomes (2)
- measure
- Proportion of patient compliant with ePROM assessment
- timeFrame
- Baseline (one-time point only)
- description
- Compliant patients are defined as patients successfully completing ePROM assessment.
- measure
- Proportion of clinical encounters using ePROM assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age 18 years or above * a verified cancer diagnosis Exclusion Criteria: * inability to fill in PROMs due to cognitive impairment, psychological disturbance or language problems as judged by the study personnel.
References
Publications (2)
- DERIVEDBrunelli 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. PMID 39842002
- DERIVEDBrunelli 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. PMID 32723341