Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information, and care on an emotional, psycho-social, and communicative level during and after the cancer experience and across healthcare sectors. Family-SCOUT is a project supported by the German Innovation Fund ( https://innovationsfonds.g-ba.de/ ). The evaluation is based on a mixed-methods quasi-experimental design with the intervention and control groups. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months of follow-up; T2: 9 months of follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. The study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher’s exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study. The results will allow to test the effectiveness and efficiency of the intervention for the target group. The first experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as the basis to assess the need of including the intervention in the catalog of services of the statutory health insurance funds in Germany. ClinicalTrials.gov , NCT04186923. Retrospectively registered on 4 December 2019.

中文翻译：

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对父母癌症家庭的全面支持 (Family-SCOUT)，复杂干预的评估：非随机对照试验的研究方案

有受父母癌症影响的未成年子女的家庭面临着巨大的情感和组织压力的风险，这会给所有家庭成员带来沉重的负担。迄今为止，受影响家庭缺乏全面的支持服务。该项目的目的是通过在癌症经历期间和之后以及跨医疗保健部门提供情感、心理社会和交流层面的建议、信息和护理，为这些家庭实施和评估复杂的心理社会干预。Family-SCOUT 是一个由德国创新基金 (https://innovationsfonds.g-ba.de/) 支持的项目。评估基于干预组和对照组的混合方法准实验设计。三个测量点的标准化邮政调查（T0：研究注册；T1：3 个月的随访；T2：9 个月的随访）、参与医疗保险基金的二手数据和半结构化定性访谈用于总结性和形成性评估。该研究的目标是包括 n=560 个家庭。数据将根据意向治疗原则进行分析。主要分析是使用 Fisher 精确检验比较干预组和对照组在 T2 时的医院焦虑和抑郁量表 (HADS) 反应率（至少两个父母中的一个的最小重要差异 (MID) ≥ 1.6）。研究的进行以及干预的制定和实施将伴随着遵循有效性-实施混合研究原则的全面研究监测。结果将允许测试干预对目标群体的有效性和效率。将提供在示范区域实施干预的第一次经验。评估结果将作为评估是否需要将干预纳入德国法定健康保险基金服务目录的依据。ClinicalTrials.gov，NCT04186923。于 2019 年 12 月 4 日追溯登记。