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开发一种由父母在家为癌症患儿和青少年进行的静脉化疗干预措施(INTACTatHome)。

Development of an intravenous chemotherapy intervention for children and adolescents with cancer administered by their parents at home (INTACTatHome).

机构信息

Department of Pediatric and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark.

出版信息

BMC Health Serv Res. 2023 Jun 20;23(1):664. doi: 10.1186/s12913-023-09613-2.

Abstract

BACKGROUND

Families of children and adolescents with cancer strive to maintain routines and normalcy during the child's treatment trajectory that requires frequent hospital visits. Intravenous chemotherapy at home can reduce time spent on the frequent hospital visits and mitigate disruption in daily life. Studies on home chemotherapy for children and adolescents with cancer are limited, as is knowledge of family and health care professionals' needs, and knowledge required to inform adaptation or replication of interventions in other settings. The aim of this study was to develop and describe an evidence-based home chemotherapy intervention that is feasible and safe for children and adolescents and suitable for future feasibility testing.

METHODS

The Medical Research Council's guidance for developing complex interventions in health care and the framework of action developed by O'Cathain et al. was used as theoretical frameworks to structure the development process. A literature search, an ethnographic study, and interviews with clinical nurse specialists from adult cancer departments formed the evidence base. Educational learning theory to support and understand the intervention was identified. Stakeholder perspectives were explored in workshops with health care professionals and parent-adolescent interviews. Reporting was qualified using the GUIDED checklist.

RESULTS

A stepwise educational program to teach parents how to administer low-dose chemotherapy (Ara-C) to their child at home and a simple and safe administration procedure were developed. Key uncertainties were identified, including barriers and facilitators impacting future testing, evaluation, and implementation. Causal assumptions and reasoning for how the intervention leads to short-term outcomes and long-term impact were clarified in a logic model.

CONCLUSIONS

The iterative and flexible framework allowed for integration of existing evidence and new data and was successfully applied to the development process. The detailed report on the development process of the home chemotherapy intervention can enhance adaptation or replication of the intervention to other settings and thereby mitigate family disruption and stress of frequent hospital visits for these treatments. The study has informed the next phase of the research project that aims to test the home chemotherapy intervention in a prospective single-arm feasibility study.

TRIAL REGISTRATION

ClinicalTrials.gov ID: NCT05372536.

摘要

背景

在需要频繁前往医院的儿童治疗过程中,癌症患儿及其家庭努力维持日常生活的常规和常态。在家中进行静脉化疗可以减少频繁前往医院的时间,并减轻日常生活的中断。在家中为癌症患儿进行化疗的研究有限,对家庭和医疗保健专业人员的需求以及为在其他环境中实施干预措施提供信息所需的知识了解有限。本研究的目的是开发和描述一种基于证据的家庭化疗干预措施,该措施对儿童和青少年既可行又安全,并且适合将来进行可行性测试。

方法

使用医疗研究委员会为医疗保健中开发复杂干预措施的指南和 O'Cathain 等人开发的行动框架作为理论框架来构建开发过程。文献检索、一项人种学研究以及对成人癌症病房的临床护士专家的访谈构成了证据基础。为了支持和理解干预措施,确定了教育学习理论。在与医疗保健专业人员和家长-青少年访谈的研讨会上探讨了利益相关者的观点。使用 GUIDED 清单对报告进行了限定。

结果

开发了一个逐步的教育计划,以教导父母如何在家中为孩子低剂量施用阿糖胞苷(Ara-C),并制定了简单安全的给药程序。确定了关键的不确定性,包括影响未来测试、评估和实施的障碍和促进因素。在逻辑模型中阐明了干预措施如何导致短期结果和长期影响的因果假设和推理。

结论

迭代和灵活的框架允许整合现有证据和新数据,并成功应用于开发过程。家庭化疗干预措施的详细开发过程报告可以增强干预措施在其他环境中的适应性或复制性,从而减轻家庭中断和频繁前往医院治疗的压力。该研究为下一阶段的研究项目提供了信息,该项目旨在前瞻性地进行一项单臂可行性研究,以测试家庭化疗干预措施。

试验注册

ClinicalTrials.gov ID:NCT05372536。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9731/10283184/86fdd67b1e8a/12913_2023_9613_Fig1_HTML.jpg

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