Quality of life questionnaire development and validation for adrenocortical carcinoma patients

Abstract ACC patients’ quality of life may be impacted by symptoms related to cancer or treatments, as well as emotional, spiritual, existential, social, economic, and sexual aspects. The aim was the development and psychometric validation of a new instrument (QoLACC) for measuring Patient Reported Outcome in patients with ACC. The study was conducted from October 2024 to January 2025 at the Oncology Unit of Brescia’s ASST. Fifteen patients and 15 physicians graded the comprehensibility/difficulty and relevance of the items of QoLACC whereas 37 consecutive patients assessed psychometric validity. Comprehensibility, difficulty and clinical relevance of the items to include in the QoLACC questionnaire were assessed by selected ACC patients and clinicians. Validated scales were co-administered to the developed QoLACC questionnaire to assess physical and psychological symptoms, and the test-retest reliability and construct validity psychometric validation were performed. The QoLACC items showed excellent content validity 0.93-1.00 and acceptable to excellent comprehensibility 0.80-1.00 and difficulty 0.80-1.00, with minor exceptions. Item analysis showed good discriminant capability and response variability. The total questionnaire has good reliability (the intraclass correlation coefficient (ICC) was 0.870 95% CI: 0.734-0.937) and construct validity proved by the moderate to strong correlations 0.39-0.62 between the QoLACC and the EORTC item 29 and item 30, the QoLACC financial section and the COST (0.47), and the QoLACC spiritual section and the JSWBS (0.60). We defined and validated the Italian questionnaire aiming to explore ACC patients’ quality of life, to help the Health Care Professionals to manage and support these patients.