Calaminus Gabriele, Baust Katja, Berger Claire, Byrne Julianne, Binder Harald, Casagranda Leonie, Grabow Desiree, Grootenhuis Martha, Kaatsch Peter, Kaiser Melanie, Kepak Tomas, Kepáková Kateřina, Kremer Leontien C M, Kruseova Jarmila, Luks Ales, Spix Claudia, van den Berg Marleen, van den Heuvel-Eibrink Marry M M, van Dulmen-den Broeder Eline, Kuonen Rahel, Sommer Grit, Kuehni Claudia
Department of Paediatric Haematology and Oncology, University Hospital Bonn, Bonn, Germany.
Department of Paediatric Haematology and Oncology, University Hospital Münster, Münster, Germany.
JMIR Res Protoc. 2021 Jan 25;10(1):e21851. doi: 10.2196/21851.
Survival after childhood cancer has improved to more than 80% during the last few years, leading to an increased number of childhood cancer survivors. Cancer itself, or its treatment, may cause chronic health conditions, including somatic and mental sequelae, which may affect survivors' health-related quality of life (HRQoL).
The project PanCareLIFE aims to establish a large database with comprehensive data on childhood cancer survivors from different European countries, including data on HRQoL. Within PanCareLIFE, this study aims to describe HRQoL in survivors, investigate predictors of HRQoL, and describe the association of HRQoL with hearing and female fertility impairment. This paper describes the design of the HRQoL study, the origin of data, strategies for data collection, and sampling characteristics of survivors from each contributing country.
A total of 6 institutions from 5 European countries (the Czech Republic, France, Germany, the Netherlands, and Switzerland) provided data on HRQoL assessed with the Short Form 36 and on relevant predictors. The central PanCareLIFE data center aggregated the data and harmonized the variables between the institutions. Survivors were eligible if they received a diagnosis of cancer according to the 12 main groups of the International Classification of Childhood Cancer, 3rd edition, or Langerhans cell histiocytosis; were aged ≤18 years at the time of diagnosis; were residents of the respective country at the time of diagnosis; had survived ≥5 years after cancer diagnosis; were aged ≥18 years at the time of the questionnaire survey; and did not refuse to registration in the national or local childhood cancer cohort.
We identified 24,993 eligible survivors. Of those, 19,268 survivors received a questionnaire and 9871 survivors participated, resulting in response rates of 9871/24,993 (39.50%) of eligible survivors and of 9871/19,268 (51.23%) invited survivors. Most participants were diagnosed with cancer between the ages of 10 and 14 years (3448/9871, 34.93%) or <5 years (3201/9871, 32.43%). The median age was 8 years. Of the 9871 participants, 3157 (31.97%) were survivors of leukemia, 2075 (21.02%) lymphoma, and 1356 (13.7%) central nervous system (CNS) tumors. Most participants (9225/9871, 93.46%) had no history of a subsequent tumor; 77.45% (7645/9871) received chemotherapy with or without other treatments. More than half (5460/9871, 55.31%) were aged 25 to 34 years at the time of the HRQoL study. Participating survivors differed from nonparticipants; participants were more often women, survivors of leukemia or lymphoma, and less frequently, survivors of CNS tumors than nonparticipants.
PanCareLIFE successfully assessed HRQoL and its predictors in 9871 European survivors of childhood cancer. This large population will permit detailed investigations of HRQoL after childhood cancer, particularly the impact of hearing and female fertility impairment on HRQoL.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/21851.
在过去几年中，儿童癌症幸存者的生存率已提高到80%以上，导致儿童癌症幸存者数量增加。癌症本身或其治疗可能会引发慢性健康问题，包括躯体和精神后遗症，这可能会影响幸存者的健康相关生活质量（HRQoL）。
PanCareLIFE项目旨在建立一个大型数据库，其中包含来自不同欧洲国家的儿童癌症幸存者的综合数据，包括HRQoL数据。在PanCareLIFE项目中，本研究旨在描述幸存者的HRQoL，调查HRQoL的预测因素，并描述HRQoL与听力和女性生育功能损害之间的关联。本文描述了HRQoL研究的设计、数据来源、数据收集策略以及每个参与国家的幸存者的抽样特征。
来自5个欧洲国家（捷克共和国、法国、德国、荷兰和瑞士）的6家机构提供了用简明健康状况调查量表（Short Form 36）评估的HRQoL数据以及相关预测因素的数据。PanCareLIFE中央数据中心汇总了这些数据，并对各机构之间的变量进行了统一。如果幸存者符合以下条件，则有资格参与研究：根据《国际儿童癌症分类》第3版的12个主要组别或朗格汉斯细胞组织细胞增多症被诊断为癌症；诊断时年龄≤18岁；诊断时是各自国家的居民；癌症诊断后存活≥5年；问卷调查时年龄≥18岁；并且不拒绝在国家或地方儿童癌症队列中登记。
我们确定了24993名符合条件的幸存者。其中，19268名幸存者收到了问卷，9871名幸存者参与了调查，符合条件的幸存者的回复率为9871/24993（39.50%），受邀幸存者的回复率为9871/19268（51.23%）。大多数参与者在10至14岁（3448/9871，34.93%）或<5岁（3201/9871，32.43%）时被诊断为癌症。中位年龄为8岁。在9871名参与者中，3157名（31.97%）是白血病幸存者，2075名（21.02%）是淋巴瘤幸存者，1356名（13.7%）是中枢神经系统（CNS）肿瘤幸存者。大多数参与者（9225/9871，93.46%）没有后续肿瘤病史；77.45%（7645/9871）接受了化疗，有或没有接受其他治疗。在进行HRQoL研究时，超过一半（5460/9871，55.31%）的参与者年龄在25至34岁之间。参与研究的幸存者与未参与者不同；与未参与者相比，参与者中女性更多，白血病或淋巴瘤幸存者更多，而CNS肿瘤幸存者更少。
PanCareLIFE成功评估了9871名欧洲儿童癌症幸存者的HRQoL及其预测因素。这个庞大的群体将有助于对儿童癌症后的HRQoL进行详细调查，特别是听力和女性生育功能损害对HRQoL的影响。
国际注册报告识别号（IRRID）：RR1-10.2196/21851。
