Expectations for Pediatric Cancer Treatment (EXPECT): A Family-Centered Intervention to Prepare Parents for Pediatric Leukemia Therapy

对儿科癌症治疗的期望 (EXPECT)：以家庭为中心的干预措施，帮助家长为儿科白血病治疗做好准备

• 批准号: 10228692
• 负责人: Katie A. Greenzang
• 金额: $ 15.21万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-19 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10228692
• 关键词: Acute; Acute Lymphocytic Leukemia; Address; Adopted; Caring; Characteristics; Child; Child Care; Childhood Acute Lymphocytic Leukemia; Childhood Cancer Treatment; Childhood Leukemia; Clinical; Clinical Trials; Communication; Complex; Consent Forms; Dana-Farber Cancer Institute; Data; Decision Making; Development; Diagnosis; Disease; Early treatment; Emotional; Family; Feedback; Future; Genomics; Glare; Goals; Health; Individual; Information Centers; Informed Consent; Intervention; Interview; Knowledge; Late Effects; Learning; Long-Term Survivors; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Medical; Mentorship; Methodology; Modeling; Multi-Institutional Clinical Trial; Multicenter Trials; Newly Diagnosed; Outcome; Parents; Patients; Pediatric Oncology; Phase III Clinical Trials; Preparation; Prognosis; Provider; Quality of life; Randomized Controlled Trials; Research; Research Infrastructure; Research Methodology; Research Personnel; Risk; Seasons; Site; Survival Rate; Survivors; System; Testing; Time; Training Activity; Treatment Protocols; Treatment Side Effects; Work; acceptability and feasibility; acute toxicity; base; cancer diagnosis; cancer therapy; career; career development; chemotherapeutic agent; chemotherapy; cognitive interview; design; expectation; experience; health communication; health literacy; implementation science; improved; individualized medicine; innovation; mathematical ability; multidisciplinary; multimodality; novel; novel strategies; optimal treatments; personalized medicine; pilot trial; prevent; prototype; randomized trial; response; risk stratification; side effect; skills; standard of care; survivorship; therapy development; treatment effect; treatment strategy; tumor; web site

PROJECT SUMMARY/ABSTRACT Though more than 80% of children with cancer will go on to be long-term survivors, most experience both acute toxicities and late effects of therapy. Despite providers' attempts to convey information about what to expect from treatment in the short- and long-term, numerous gaps in parental understanding remain. Most parents do not have an accurate understanding of their child's prognosis or risk of late effects of treatment, and as a result, many feel poorly prepared for treatment experiences and survivorship. To address these gaps, the proposed project will develop and pilot test Expectations for Pediatric Cancer Treatment (EXPECT), the first family-centered intervention to improve communication and information about pediatric cancer therapy at diagnosis. EXPECT will have two components, written materials summarizing key information about treatment and side effects for use during the informed consent conversation with providers, and a website for parents which will contain more detailed information including videos of actual parents and children describing their treatment experiences. Using stakeholder interviews and iterative feedback, we will develop and refine EXPECT for use in initial informed consent conversations in pediatric acute lymphoblastic leukemia (ALL), the most common malignancy of childhood. We will then test the intervention in 30 treatment conversations in ALL, assessing feasibility and acceptability, and evaluating preliminary outcomes relative to 30 parents who did not receive the intervention. This proposal has the following 3 interrelated and complimentary aims: 1) To determine information needs and optimal strategies for sharing early treatment information through qualitative stakeholder interviews of parents, survivors, and providers. 2) To design and refine a prototype EXPECT using Aim 1 qualitative data and input from a multidisciplinary steering committee with disease and methodologic expertise including parent advisors. 3) To evaluate feasibility, acceptability, and preliminary outcomes of EXPECT in a pilot trial within the current Dana-Farber Cancer Institute (DFCI) ALL Consortium multi- institutional clinical trial. At the conclusion of the proposed study, the resultant intervention, EXPECT, will be ready for testing in a randomized controlled trial (planned R01). Throughout the study, the PI, Dr. Greenzang, will be supported by a seasoned mentorship team and advisory panel with expertise in health communication, intervention development, and implementation science. She will engage in career development and training activities focused on qualitative and quantitative research methods, implementation science, and conduct of multicenter trials to prepare her for a career as an independent investigator, all while pioneering the first patient- and family-centered communication intervention in pediatric oncology. In so doing, she will not only develop an approach to optimally prepare all parents of children with cancer for their children's care during treatment and beyond, but also expand our knowledge of what type of information patients and families desire at the time of cancer diagnosis and how best to transmit that information.

项目概要/摘要 尽管超过 80% 的癌症儿童将成为长期幸存者，但大多数都经历过这两种情况 急性毒性和治疗的迟发效应。尽管提供商试图传达有关内容的信息 尽管从短期和长期的治疗来看，父母的理解仍然存在许多差距。最多 父母对孩子的预后或治疗后期影响的风险没有准确的了解，并且 因此，许多人感觉自己对治疗经历和生存准备不足。为了解决这些差距， 拟议项目将开发并试点测试儿科癌症治疗期望 (EXPECT)，这是第一个 以家庭为中心的干预措施，以改善儿科癌症治疗的沟通和信息 诊断。 EXPECT 将由两个部分组成，书面材料总结有关治疗的关键信息 和与提供者进行知情同意对话期间使用的副作用，以及家长网站 其中将包含更详细的信息，包括实际父母和孩子描述他们的情况的视频 治疗经验。通过利益相关者访谈和迭代反馈，我们将开发和完善 EXPECT 用于小儿急性淋巴细胞白血病 (ALL) 的初步知情同意对话， 儿童期最常见的恶性肿瘤。然后我们将在 ALL 的 30 次治疗对话中测试干预措施， 评估可行性和可接受性，并评估相对于 30 位没有这样做的家长的初步结果 接受干预。该提案有以下 3 个相互关联且互补的目标： 1) 通过定性确定信息需求和共享早期治疗信息的最佳策略 对父母、幸存者和提供者的利益相关者进行访谈。 2) 设计和完善原型 EXPECT 使用 目标 1 来自疾病和方法学多学科指导委员会的定性数据和输入 专业知识，包括家长顾问。 3) 评估可行性、可接受性和初步结果 EXPECT 在目前的丹纳法伯癌症研究所 (DFCI) ALL 联盟内进行的一项试点试验中 机构临床试验。在拟议研究结束时，最终的干预措施 EXPECT 将是 准备在随机对照试验中进行测试（计划 R01）。在整个研究过程中，PI Greenzang 博士 将得到经验丰富的导师团队和具有健康传播专业知识的顾问小组的支持， 干预开发和实施科学。她将从事职业发展和培训 活动侧重于定性和定量研究方法、实施科学以及开展 多中心试验让她为独立调查员的职业生涯做好准备，同时开创了第一个 儿科肿瘤学中以患者和家庭为中心的沟通干预。这样做，她不仅会 制定一种方法，让所有患有癌症的儿童的父母在治疗期间为孩子的护理做好最佳准备 治疗及其他方面，同时也扩大了我们对患者和家属想要什么类型的信息的了解 癌症诊断时以及如何最好地传递该信息。