Calaminus G, Jenney M, Hjorth L, Baust K, Bernstein M, Bielack S, Vos P, Hogendoorn PCW, Jovic G, Krailo M, Kreitz K, Marina N, Popoola BO, Sauerland C, Smeland S, Teske C, Schweinitz CV, Whelan J, Wiener A, Sydes MR, Nagarajan R. Quality of Life of Patients With Osteosarcoma in the European American Osteosarcoma Study-1 (EURAMOS-1): Development and Implementation of a Questionnaire Substudy. JMIR Res Protoc. 2019 Sep 26;8(8):e14406. doi: 10.2196/14406. PubMed PMID: 31573951; PubMed Central PMCID: PMC6819132.
Study ID Citation
Abstract
The quality of life (QoL) of patients with osteosarcoma (OS) may be adversely affected by the disease or its treatment. Therefore, it is important to understand the QoL of patients undergoing treatment for OS to improve the QoL. We report on the first prospective international QoL study that was embedded within a large randomized clinical trial from 4 national study groups. This paper aimed to describe the QoL study development, methodology, accrual details, and characteristics of the QoL cohort. A total of 2260 patients registered in the EURopean AMerican Osteosarcoma Study-1 (EURAMOS-1), of whom 97.92% (2213/2260) were eligible for the optional QoL assessment and could participate in terms of questionnaire availability. Overall, 61.86% (1369/2213) of patients and/or proxies completed the QoL evaluation at the first assessment time point (E1) after the start of preoperative treatment. The QoL measures used (self- and/or proxy reports) depending on the patient’s age and national study group. Participants and nonparticipants in the ancillary QoL study were compared regarding relevant demographic and disease-related characteristics at registration in the trial.