Validation of the Italian Version of the PRO-CTCAE

Study Overview
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Brief Summary
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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.

Detailed Description
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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: EORTC Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available. the Hospital Anxiety and Depression Scale (HADS) The Patients' Global Impression of Change (PGIC) Scale

Official Title
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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

Conditions
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Malignant Neoplasms

Intervention / Treatment
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* Other: PRO-CTCAE items


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PRO-CTCAE items|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: the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available. the Hospital Anxiety and Depression Scale (HADS) The Patients' Global Impression of Change (PGIC) Scale.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in psychometric measures according to tumor type and treatment | Evaluate any differences in psychometric measures according to: type of cancer (breast, lung, liver ...) type of treatment (chemotherapy, hormone therapy, immunotherapy, ...) | at 3 weeks (up to 6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Performance Status, Quality of Life, PRO-CTCAE, EORTC QLQ-C30 or Disease-Specific Questionnaire, HADS, PGIC Scale