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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.
This is a prospective observational study, conducted in Italian cancer centers located Nationwide.
The investigators plan to consider for validation 21tumor sites, which correspond to the conditions for which a specific EORTC module has been produced, plus all remaining cancer types classified as "other setting".
The study will take place during two planned visits, one the first the day of enrollment, the second after 3-6 weeks. Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-CTCAE items | Other | Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:
|
| Measure | Description | Time Frame |
|---|---|---|
| Validity of the italian version of the PRO-CTCAE | 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 | at baseline (up to 3weeks) |
| Validity of the italian version of the PRO-CTCAE | 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 | at 3 weeks (up to 6 weeks) |
| Responsiveness of the italian version of the PRO-CTCAE | 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. | at baseline (up to 3 weeks) |
| Responsiveness of the italian version of the PRO-CTCAE | 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. | at 3 weeks (up to 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in psychometric measures according to tumor type and treatment | Evaluate any differences in psychometric measures according to:
| at 3 weeks (up to 6 weeks) |
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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:
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Any type of cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Perrone, MD, PhD | Contact | +390815903571 | +390815903571 | f.perrone@istitutotumori.na.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Perrone, MD, PhD | Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncologia Medica per la Patologia Toracica- IRCCS Giovanni Paolo II | Recruiting | Bari | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39059033 | Derived | Caminiti 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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