Parents' Experiences in Pediatric Oncology Phase 1 Clinical Trials

 描述（由申请人提供）：患有癌症的儿童只有在癌症无法治愈时才参加I期临床试验（P1 T）;参加这些试验的儿童的平均预期寿命只有五个月。虽然75%的儿童将在一年内死亡，但父母主要是基于治愈和延长生命的希望来招收儿童，尽管这并不反映P1 Ts的目的。父母登记的其他原因包括确保护理的连续性，保持生活质量和利他主义。P1 Ts给儿童带来额外的医疗程序和毒性负担，并可能增加儿童和父母的痛苦，限制姑息治疗的机会，并破坏死亡和丧亲过程。虽然护士在整个P1 T中支持儿童和父母方面发挥着关键作用，但很少有经验证据可以指导这一独特人群的护理。这项研究是了解儿科肿瘤P1 T的生活经验的第一步。本研究的目的是：（1）作为P1 T同意过程的一部分，为医生和护士提供重要信息;（2）作为未来干预开发的基础，以增强参与P1 T的父母和儿童的经验。具体的目的是开发一个丰富的，深入的，现象学的描述父母的经验，有一个孩子患有癌症参与P1 T。现象学研究是用来描述意义的共同性，在生活经验的人在类似的生活情况。基于Colaizzi的方法，一个经验现象学的方法，计划确定共性和构建父母的生活经验的基本结构。通过单一的非结构化访谈（持续约60分钟），父母将充分描述他们的孩子在参与P1 T期间的经历。7至10天后，将对每位参与者进行后续电话调查，以评估是否存在造成过度痛苦的迹象。在分析数据并撰写叙述后，将联系随机抽样的参与者以验证基本结构。为了提供所述经历的背景，将填写人口统计表，并从签署的P1 T知情同意书中提取P1 T相关信息。预期的结果是父母的经验，在他们的孩子参与P1 T的深入描述。这一描述将促进循证同意过程，指导干预研究，重点是增强儿童和父母在P1 T期间的体验，并最终减轻负担，改善儿童和父母的福祉，他们在生命中的这个关键时刻为新型癌症疗法的发展做出了贡献。

 DESCRIPTION (provided by applicant): Children with cancer are only enrolled in a phase I clinical trial (P1T) when their cancer is incurable; the mean life expectancy of children enrolled in these trials is just five months. Although 75% of the children will die within a year, parents primarily enroll children based on hope of cure and prolonging life, though this does not reflect the purpose of P1Ts. Parents' other reasons for enrollment include ensuring continuity of care, maintaining quality of life, and altruism. P1Ts burden children with additional medical procedures and toxicities, and may increase child and parent suffering, limit palliation opportunities, and disrupt the dying and bereavement processes. Although nurses play a key role in supporting children and parents throughout the P1T, minimal empirical evidence exists to guide nursing caring for this unique population. This study is the first step towards understanding the lived experience of pediatric oncology P1Ts. The purposes of this study are to: (1) contribute vital information for use by physicians and nurses as part of the P1T consent process; and (2) serve as a foundation for future intervention development to enhance the experience of parents and children participating in P1Ts. The specific aim is to develop a rich, in-depth, phenomenological description of parents' experiences of having a child with cancer participate in a P1T. Phenomenological research is used to describe commonalities of meaning in the lived experiences of people in similar life situations. Based on Colaizzi's methods, an empirical phenomenological approach is planned to identify commonalities and construct an essential structure of parents' lived experiences. Through single unstructured interviews (lasting approximately 60 minutes), parents will fully describe their experiences during their child's participation in a P1T. A follow-up call to each participant 7 to 10 days later will assess for indications of resulting undue distress. After data are analyzed and narratives written, a random sample of participants will be contacted to validate the essential structure. To provide context fo described experiences, a demographic form will be completed and information regarding the P1T will be abstracted from the signed P1T consent. The expected outcome is an in-depth description of parents' experiences during their child's participation in a P1T. This description will facilitate evidence-based consent processes, guide intervention research focused on enhancing the child and parent experience during P1Ts, and ultimately decrease the burdens and improve the well-being of children and parents who contribute to the development of novel cancer therapies at this crucial time in their lives.