Quality of Life of Patients With Osteosarcoma in the European American Osteosarcoma Study-1 (EURAMOS-1): Development and Implementation of a Questionnaire Substudy

Gabriele Calaminus; Meriel Jenney; Lars Hjorth; Katja Baust; Mark Bernstein; Stefan Bielack; Patricia De Vos; Pancras C W Hogendoorn; Gordana Jovic; Mark Krailo; Kiana Kreitz; Neyssa Marina; Babasola O Popoola; Cristina Sauerland; Sigbjørn Smeland; Carmen Teske; Clara V Schweinitz; Jeremy Whelan; Andreas Wiener; Matthew R Sydes; Rajaram Nagarajan

doi:10.2196/14406

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.

Authors

Gabriele Calaminus¹, Meriel Jenney², Lars Hjorth³, Katja Baust¹, Mark Bernstein⁴, Stefan Bielack⁵, Patricia De Vos⁶, Pancras C W Hogendoorn⁷, Gordana Jovic⁸, Mark Krailo^{9

10}, Kiana Kreitz¹¹, Neyssa Marina¹², Babasola O Popoola⁸, Cristina Sauerland¹¹, Sigbjørn Smeland^{13

14}, Carmen Teske¹, Clara V Schweinitz¹, Jeremy Whelan¹⁵, Andreas Wiener¹⁶, Matthew R Sydes⁸, Rajaram Nagarajan^{17

18}

Affiliations

¹ Department of Pediatric Hematology and Oncology, University Hospital Bonn, Bonn, Germany.
² Children & Women's Services Clinical Board, University Hospital of Wales, Cardiff, United Kingdom.
³ Pediatrics, Department of Clinical Sciences Lund, Skane University Hospital, Lund University, Lund, Sweden.
⁴ IWK Health Centre, Dalhousie University, Halifax, NS, Canada.
⁵ Cooperative Osteosarcoma Study Group, Klinikum Stuttgart - Olgahospital, Stuttgart, Germany.
⁶ Department of Pediatric Hematology and Oncology, Gent University Hospital, Gent, Belgium.
⁷ Department of Pathology, Leiden University Medical Center, Leiden, Netherlands.
⁸ MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, United Kingdom.
⁹ Department of Preventive Medicine, Keck Medical Center at the University of Southern California, Los Angeles, CA, United States.
¹⁰ Children's Oncolgy Group, Arcadia, CA, United States.
¹¹ Institute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany.
¹² Five Prime Therapeutics Inc, South San Francisco, CA, United States.
¹³ Division of Cancer Medicine and Scandinavian Sarcoma Group, Oslo University Hospital, Oslo, Norway.
¹⁴ Institute for Clinical Medicine, University of Oslo, Oslo, Norway.
¹⁵ Department of Oncology, University College Hospital, London, United Kingdom.
¹⁶ West German Proton Therapy Centre Essen, Essen, Germany.
¹⁷ Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States.
¹⁸ Division of Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.

PMID: 31573951
PMCID: PMC6819132
DOI: 10.2196/14406

Abstract

Background: 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.

Objective: This paper aimed to describe the QoL study development, methodology, accrual details, and characteristics of the QoL cohort.

Methods: 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.

Results: The participation rate at time point E1 did not differ with regard to age, gender, the occurrence of pathological fracture, or the presence of any metastases at diagnosis. No differences were found regarding the primary tumor site. Only the national study group affiliation had an influence on participation. Participation decreased linearly with trial progress up to 20% at the final time point of QoL assessment.

Conclusions: This study demonstrates the feasibility of international cooperation for the purpose of assessing and understanding the QoL of pediatric and adolescent/young adult patients with cancer. Future outcomes of this QoL substudy will help to adapt interventions to improve QoL.

Keywords: adolescent; cancer; child; observational study; osteosarcoma; quality of life; sarcoma; survivors of childhood cancer; young adult.

©Gabriele Calaminus, Meriel Jenney, Lars Hjorth, Katja Baust, Mark Bernstein, Stefan Bielack, Patricia De Vos, Pancras C W Hogendoorn, Gordana Jovic, Mark Krailo, Kiana Kreitz, Neyssa Marina, Babasola O Popoola, Cristina Sauerland, Sigbjørn Smeland, Carmen Teske, Clara V Schweinitz, Jeremy Whelan, Andreas Wiener, Matthew R Sydes, Rajaram Nagarajan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.09.2019.

Abstract

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