An observational study in Malignant Neoplasms, sponsored by National Cancer Institute, Naples. Status unknown at 25 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by National Cancer Institute, Naples · Observational
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:
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 3,675 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any type of cancer
Diagnosis of any type of cancer
•≥18 years of age.
Exclusion Criteria:
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.
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: at 3 weeks (up to 6 weeks)
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, ...)
Time frame: at 3 weeks (up to 6 weeks)
Plan to share: No
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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National Cancer Institute, Naples