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In Italy, the role of a nurse in cancer research is beginning to develop, but instruments developed to delineate the dimensions of the Italian clinical trials nursing role are lacking. This study aimed to translate into Italian the Clinical Trials Nursing Questionnaire (CTNQ) and assess its content validity, internal consistency, and stability reliability. Forward-backward translation and review by experts were performed to assess linguistic and content validation. Internal consistency reliability was computed using Cronbach alpha and by administering the translated CTNQ to a sample of 30 research nurses coming from different Italian districts. To determine the test-retest reliability, a copy of the questionnaire was given again to a subgroup of 10 research nurses. The pretest and posttest scores were compared using kappa coefficient. The comparison of the target language version with the original version allowed us to consider the translation of CTNQ as acceptable. The analyses revealed a Cronbach alpha coefficient of .98 for the frequency scale and .96 for the importance scale. The overall kappa coefficient was 0.98 for the frequency scale and 0.99 for the importance scale. The CTNQ is a valid and reliable instrument for the assessment of the research nurse's role in Italy.

Background Few data are available on the safety of COVID-19 vaccines in cancer patients undergoing active cancer-directed treatment. Patients and Methods This case series analyzes outcomes in terms of adverse events in 5297 patients undergoing anti-cancer treatment who were vaccinated with anti-SARS-CoV-2 Pfizer-BioNTech vaccine at a single cancer center from March 6, 2021 to May 9, 2021. Adverse events were retrieved from the national Italian pharmacovigilance platform (http://www.vigicovid.it). Results Of the 5297 patients treated for either solid tumors (87%) or onco-hematologic malignancies (13%) who were vaccinated, 8 adverse drug reactions (ADRs) were reported. One was a severe ADR and 7 were non-severe ADRs. Non-severe ADRs resolved within 48 hours. Conclusion BNT162b2 Pfizer-BioNTech vaccine was safely administered in the largest cohort of cancer patients reported to date.