Objectives

Phase 1 clinical trials are essential in the development of novel therapies for childhood cancers. Children with cancer can participate in phase 1 clinical trials when no known curative therapy remains. Understanding the experiences of children and their families in these clinical trials can help ensure that participation supports the children's and parents’ well-being. This article explores the specific aspects of pediatric oncology phase 1 trials that parents found particularly challenging.

Data Sources

This qualitative, empirical phenomenology study considered 11 parents’ experiences during the time their child with cancer participated in a phase 1 clinical trial. The primary study results were previously reported. This article reports parents’ insights into the processes and procedures that occurred as part of participation in a pediatric oncology phase 1 trial.

Conclusion

Parents’ experiences during the phase 1 clinical trials were primarily positive. However, data analysis revealed five aspects of these trials that were challenging for families: learning about clinical trials, being referred to another institution, research-only procedures, adhering to trial requirements, and oral medications.

Implications for Nursing Practice

Although experiences during phase 1 clinical trials were positive overall, opportunities to enhance children's and parents’ experiences warrant attention. Enhancing the education provided to families during recruitment and minimizing the logistical burdens associated with trial requirements through care coordination may alleviate challenges experienced by children and parents.

中文翻译：

---

家长对儿科肿瘤一期临床试验的见解：孩子参与的经验

目标

一期临床试验对于开发儿童癌症新疗法至关重要。当没有已知的治疗方法时，患有癌症的儿童可以参加一期临床试验。了解儿童及其家人在这些临床试验中的经历有助于确保参与支持儿童和家长的福祉。本文探讨了家长认为特别具有挑战性的儿科肿瘤学一期试验的具体方面。

数据源

这项定性、实证现象学研究考虑了 11 位父母在其患有癌症的孩子参加一期临床试验期间的经历。初步研究结果先前已报道。本文报告了家长对参与儿科肿瘤学 1 期试验过程和程序的见解。

结论

父母在第一阶段临床试验中的经历主要是积极的。然而，数据分析揭示了这些试验的五个方面对家庭来说具有挑战性：了解临床试验、被转介到另一个机构、仅限研究的程序、遵守试验要求和口服药物。

对护理实践的影响

尽管第一阶段临床试验的体验总体上是积极的，但增强儿童和家长体验的机会值得关注。在招募过程中加强向家庭提供的教育，并通过护理协调尽量减少与试验要求相关的后勤负担，可能会减轻儿童和家长面临的挑战。