Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
BMJ Open. 2017 Aug 11;7(8):e014505. doi: 10.1136/bmjopen-2016-014505.
For ill children as well as for their parents and siblings, childhood cancer poses a major challenge. Little is known about the reintegration into daily life of childhood cancer survivors and their families. The aim of this prospective observational study is to further the understanding of the role of rehabilitation measures in the reintegration process of childhood leukaemia or brain tumour survivors and their family members after the end of cancer treatment.
This prospective observational study consists of three study arms: a quantitative study in cooperation with three German paediatric oncological study registries (study arm 1), a quantitative study in cooperation with a rehabilitation clinic that offers a family-oriented paediatric oncological rehabilitation programme (study arm 2) and a qualitative study at 12-month follow-up including families from the study arms 1 and 2 (study arm 3). In study arm 1, children, parents and siblings are surveyed after treatment (baseline), 4-6 months after baseline measurement and at 12-month follow-up. In study arm 2, data are collected at the beginning and at the end of the rehabilitation measure and at 12-month follow-up. Families are assessed with standardised questionnaires on quality of life, emotional and behavioural symptoms, depression, anxiety, fear of progression, coping and family functioning. Furthermore, self-developed items on rehabilitation aims and reintegration into daily life are used. Where applicable, users and non-users of rehabilitation measures will be compared regarding the outcome parameters. Longitudinal data will be analysed by means of multivariate analysis strategies. Reference values will be used for comparisons if applicable. Qualitative data will be analysed using thematic analysis.
This study has been approved by the medical ethics committee of the Medical Chamber of Hamburg. Data will be published in peer-reviewed journals and presented at conferences.
对于患病的儿童及其父母和兄弟姐妹而言，儿童癌症是一个重大挑战。对于癌症幸存者及其家庭重新融入日常生活的情况，人们知之甚少。本前瞻性观察研究旨在深入了解康复措施在癌症治疗结束后，白血病或脑瘤儿童幸存者及其家庭成员重新融入生活过程中的作用。
本前瞻性观察研究包括三个研究组：与三个德国儿科肿瘤学研究登记处合作的定量研究（研究组 1）、与提供面向家庭的儿科肿瘤康复计划的康复诊所合作的定量研究（研究组 2）以及在 12 个月随访时进行的包括研究组 1 和 2 中的家庭的定性研究（研究组 3）。在研究组 1 中，在治疗后（基线）、基线测量后 4-6 个月和 12 个月随访时对儿童、父母和兄弟姐妹进行调查。在研究组 2 中，在康复措施开始时和结束时以及 12 个月随访时收集数据。使用标准化问卷评估家庭的生活质量、情绪和行为症状、抑郁、焦虑、对进展的恐惧、应对方式和家庭功能。此外，还使用关于康复目标和重新融入日常生活的自我制定项目。如有可能，将比较康复措施的使用者和非使用者在结果参数方面的情况。将使用多元分析策略分析纵向数据。在适用的情况下，将使用参考值进行比较。定性数据将使用主题分析进行分析。
本研究已获得汉堡医疗协会医学伦理委员会的批准。数据将发表在同行评议的期刊上，并在会议上展示。
