RESUMEN
Chemotherapy-induced neurotoxicity is a well-known complication of several very effective systemic anticancer treatments, mainly presenting as cognitive impairment ("chemo-brain") and peripheral neuropathy. The social and economic effects of long-lasting chemotherapy-induced neurotoxicity on patients' lifestyles and their relationships are under-investigated, and their impact is, therefore, largely unknown. In this study, we used a web-based questionnaire to record the self-reported perception of chemotherapy-induced neurotoxicity on cancer patients' health status, but also on several different aspects of their daily life. From the study results, it emerged that the impact of chemotherapy-induced neurotoxicity on personal, social, and working activities is very high. A similar effect was also observed when the psychological impact is assessed. Moreover, there is evidence suggesting that the management of CIPN is suboptimal; this is partially due to a lack of effective drugs, but also of appropriate advice from healthcare providers. In conclusion, this study provides evidence for the relevance of the impact on the explored aspects of the daily life of cancer patients and spotlights the need for a larger and more structured investigation on these long-term side effects of anticancer chemotherapy.
RESUMEN
INTRODUCTION: US National Cancer Institute's (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) is a library of 78 symptom terms and 124 items enabling patient reporting of symptomatic adverse events in cancer trials. This multicenter study used mixed methods to develop an Italian language version of this widely accepted measure, and describe the content validity and reliability in a diverse sample of Italian-speaking patients. METHODS: All PRO-CTCAE items were translated in accordance with international guidelines. Subsequently, the content validity of the PRO-CTCAE-Italian was explored and iteratively refined through cognitive debriefing interviews. Participants (n=96; 52% male; median age 64 years; 26% older adults; 18% lower educational attainment) completed a PRO-CTCAE survey and participated in a semi-structured interview to determine if the translation captured the concepts of the original English language PRO-CTCAE, and to evaluate comprehension, clarity and ease of judgement. Test-retest reliability of the finalized measure was explored in a second sample (n=135). RESULTS: Four rounds of cognitive debriefing interviews were conducted. The majority of PRO-CTCAE symptom terms, attributes and associated response choices were well-understood, and respondents found the items easy to judge. To improve comprehension and clarity, the symptom terms for nausea and pain were rephrased and retested in subsequent interview rounds. Test-retest reliability was excellent for 41/49 items (84%); the median intraclass correlation coefficient was 0.83 (range 0.64-0.94). DISCUSSION: Results support the semantic, conceptual and pragmatic equivalence of PRO-CTCAE-Italian to the original English version, and provide preliminary descriptive evidence of content validity and reliability.
