Clinical trial · Observational
Validation of the Italian Version of the PRO-CTCAE
VIP: Validation of the Italian Version of the Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Prospective Multicenter Observational Study on Different Cancer Types
- 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)
The aim of this study is to complete the validation process by testing the remaining two psychometric properties (validity and responsiveness) of the Italian version of the PRO-CTCAE in a large group of patients. In particular, for the first time this study will validate the tool for individual types of cancer and will provide information on psychometric properties based on the type of treatment used in clinical practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasms | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRO-CTCAE items | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Validity of the italian version of the PRO-CTCAE
- timeFrame
- at baseline (up to 3weeks)
- description
- Evaluation of the validity (degree to which an instrument accurately measures the underlying phenomenon) of single items of the PRO-CTCAE, Italian version, for each of the type of cancer considered
- measure
- Validity of the italian version of the PRO-CTCAE
- timeFrame
- at 3 weeks (up to 6 weeks)
- description
- Evaluation of the validity (degree to which an instrument accurately measures the underlying phenomenon) of single items of the PRO-CTCAE, Italian version, for each of the type of cancer considered
- measure
- Responsiveness of the italian version of the PRO-CTCAE
- timeFrame
- at baseline (up to 3 weeks)
- description
- Evaluation of responsiveness (ability of an instrument to show a change when there has been a change in the phenomenon) of single items of the PRO-CTCAE for each of the types of cancer considered.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of any type of cancer •≥18 years of age. * Female or male * With at least two planned clinic visits (a return visit within 3-6 weeks) to avoid the need of extra visits * Actively receiving treatment for cancer (going to receive the second or further cycle) * Any ECOG performance status (PS) * Able to complete questionnaire by themselves or with assistance, by using a tablet * Able to speak and understand Italian * Providing informed written consent Exclusion Criteria: * Having any kind of psychiatric disorder or major cognitive dysfunction hampering the provision of informed consent. * Having received more than 5lines of therapies * Currently participating in other trials which imply the completion of Patient Reported Outcomes (PROs) in the same period * Other important acute medical conditions.
References
Publications (1)
- DERIVEDCaminiti C, Maglietta G, Arenare L, Di Liello R, Migliaccio G, Barberio D, De Laurentiis M, Di Rella F, Nuzzo F, Pacilio C, Iodice G, Orditura M, Ciardiello F, Di Bella S, Cavanna L, Porta C, Giovanardi F, Ripamonti CI, Bilancia D, Aprile G, Ruelle T, Diodati F, Piccirillo MC, Iannelli E, Pinto C, Perrone F. Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE(R)) in breast cancer patients: The prospective observational multicenter VIP study. Breast. 2024 Oct;77:103781. doi: 10.1016/j.breast.2024.103781. Epub 2024 Jul 20. PMID 39059033