Parents' Experiences in Pediatric Oncology Phase 1 Clinical Trials

家长在儿科肿瘤学 1 期临床试验中的经验

基本信息

  • 批准号:
    9335672
  • 负责人:
  • 金额:
    $ 0.45万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2015
  • 资助国家:
    美国
  • 起止时间:
    2015-09-01 至 2017-09-30
  • 项目状态:
    已结题

项目摘要

 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.
 描述(由申请人提供):癌症儿童只有在癌症无法治愈的情况下才能参加I期临床试验(P1T);参加这些试验的儿童的平均预期寿命仅为5个月。尽管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P1TS的目的。父母注册的其他原因包括确保护理的连续性,保持生活质量,以及利他主义。P1TS给儿童带来额外的医疗程序和毒性,并可能增加儿童和父母的痛苦,限制姑息机会,并扰乱死亡和丧亲过程。尽管护士在整个P1T中扮演着支持儿童和父母的关键角色,但存在着最少的经验证据来指导护理照顾这一独特的人群。这项研究是了解儿科肿瘤学P1T的生活经验的第一步。这项研究的目的是:(1)提供重要信息,供医生和护士作为P1T同意过程的一部分使用;(2)作为未来干预发展的基础,以增强参与P1T的父母和儿童的体验。其具体目的是对父母让癌症孩子参与P1T的经历进行丰富、深入的现象学描述。现象学研究被用来描述处于相似生活情境中的人的生活经验中意义的共性。基于Colaizzi的方法,我们计划用一种经验现象学的方法来识别共性,并构建父母生活经验的基本结构。通过单次非结构化访谈(持续约60分钟),家长将全面描述他们在孩子参加P1T期间的经历。7至10天后,对每个参与者的后续电话将评估由此产生的不必要痛苦的迹象。在分析数据和编写叙述后,将联系随机抽样的参与者,以验证基本结构。为了提供所描述的经历的背景,将填写一份人口统计表,并从签署的P1T同意书中提取关于P1T的信息。预期的结果是对父母在孩子参加P1T期间的经历的深入描述。这一描述将促进基于证据的同意过程,指导干预研究,重点是增强儿童和父母在P1T期间的体验,并最终减轻在生命中这一关键时刻为开发新型癌症疗法做出贡献的儿童和父母的负担和福祉。

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Stacey Crane其他文献

Stacey Crane的其他文献

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{{ truncateString('Stacey Crane', 18)}}的其他基金

Facilitating Comprehensive Self and Proxy Symptom Assessments for Children with Cancer
促进癌症儿童的全面自我和代理症状评估
  • 批准号:
    10216071
  • 财政年份:
    2021
  • 资助金额:
    $ 0.45万
  • 项目类别:
Facilitating Comprehensive Self and Proxy Symptom Assessments for Children with Cancer
促进癌症儿童的全面自我和代理症状评估
  • 批准号:
    10592415
  • 财政年份:
    2021
  • 资助金额:
    $ 0.45万
  • 项目类别:
Facilitating Comprehensive Self and Proxy Symptom Assessments for Children with Cancer
促进癌症儿童的全面自我和代理症状评估
  • 批准号:
    10374939
  • 财政年份:
    2021
  • 资助金额:
    $ 0.45万
  • 项目类别:
Parents' Experiences in Pediatric Oncology Phase 1 Clinical Trials
家长在儿科肿瘤学 1 期临床试验中的经验
  • 批准号:
    9195616
  • 财政年份:
    2015
  • 资助金额:
    $ 0.45万
  • 项目类别:
Parents' Experiences in Pediatric Oncology Phase 1 Clinical Trials
家长在儿科肿瘤学 1 期临床试验中的经验
  • 批准号:
    8977251
  • 财政年份:
    2015
  • 资助金额:
    $ 0.45万
  • 项目类别:
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