Video Informed Consent Tools to Improve Care for Patients With Advanced Pancreatic Cancer

 描述(由申请人提供)：建议研究的目的是通过开发和测试以患者为中心的干预措施来提高临终癌症护理的质量，以便更好地告知晚期胰腺癌患者预后及其化疗方案的风险/益处。无法治愈的癌症患者对预后有着明显的乐观预期，而且经常接受姑息化疗，而没有意识到它不太可能治愈。这些误解与偏爱重症监护、缺乏预先护理规划、临终关怀未得到充分利用以及 停产护理。这些低质量的EOL护理的标志给患者和他们失去亲人的照顾者带来了过度的痛苦，没有客观的好处。然而，提高晚期癌症患者预后认识的干预措施很少，而且不发达。在开始治疗之前，肿瘤学家通常会讨论化疗的风险和好处，患者需要签署书面知情同意书。这项建议将化疗知情同意(IC)过程作为一个战略机会，使患者更好地了解他们的疾病和治疗方案。在她的试点工作的基础上，在Aim 1)，Enzinger博士将开发一套视频和配套手册，以支持IC用于晚期胰腺癌化疗，满足患者和护理人员在焦点小组测试中确定的预后信息需求。IC视频将提供关于化疗风险和好处的循证信息，提供关于胰腺癌及其预后的背景，并以患者分享他们的经验为特色。在目标2和3)中，一项试点随机试验将评估干预对患者对预后和化疗益处的了解、对EOL护理质量的核心过程(例如，提前护理计划)以及随后的EOL护理的强度和质量的影响。这一干预措施是实用的、可扩展的，并具有积极影响向晚期癌症患者提供的护理质量的巨大潜力。这项研究将促进对候选人职业目标至关重要的三个领域的培训：健康沟通、社会行为研究和统计学，在这些领域，她已经规划了严格的课程。恩辛格博士有两位资历很高且尽职尽责的导师：德布·施拉格博士和霍莉·普里格森博士，前者是癌症护理提供领域的知名研究员，后者是临终社会行为研究的领军人物。她的顾问团在健康传播、定性研究、心理测量学和社会行为干预方面拥有深厚而多样的专业知识。恩辛格博士是达纳-法伯癌症研究所的卫生服务研究员、内科肿瘤学家和姑息治疗内科医生，她的职位同样为她的职业生涯提供了一个理想的环境。总之，拟议的研究和职业发展计划将使候选人能够实现她的研究目标，为她的干预措施的最终研究获得未来的R01资金，并帮助她作为一名独立调查员开始职业生涯，致力于通过开发和实施新的沟通干预措施来加强EOL癌症护理。

 DESCRIPTION (provided by applicant): The object of the proposed study is to enhance the quality of end-of-life (EOL) cancer care by developing and testing a patient-centered intervention to better inform patients with advanced pancreatic cancer about prognosis and the risks/benefits of their chemotherapy options. Patients with incurable cancer harbor markedly optimistic expectations of prognosis, and often receive palliative chemotherapy without appreciating that it is unlikely to cure. Such misconceptions have been linked to preference for intensive care, lack of advance care planning, underutilization of hospice and greater intensity of EOL care. These markers of poor quality EOL care cause excess suffering for patients and their bereaved caregivers, without objective benefit. Nevertheless, interventions to enhance advanced cancer patients' prognostic understanding are few and underdeveloped. Prior to starting treatment, oncologists typically discuss the risks and benefits of chemotherapy and patients are required to sign written informed consent. This proposal capitalizes on the chemotherapy informed consent (IC) process as a strategic opportunity to equip patients with a better understanding of their illness and treatment options. Building upon her pilot work, in Aim 1) Dr. Enzinger will develop a suite of videos and companion booklets to support IC for advanced pancreatic cancer chemotherapy, which attend to the prognostic information needs identified by patients and caregivers in focus group testing. IC videos will present evidence-based information about chemotherapy risks and benefits, offer context about pancreatic cancer and its prognosis, and feature patients sharing their experiences. In Aims 2 & 3) a pilot randomized trial will evaluate the impact of the intervention on patients' understanding of prognosis and chemotherapy benefits, on processes central to EOL care quality (e.g. advance care planning), and subsequent intensity and quality of EOL care. This intervention is practical, scalable and has immense potential to positively impact the quality of care provided to patients with advanced cancer. This research will facilitate training in three areas vital to the candidate' career goals: health communications, socio-behavioral research, and statistics, in which she has planned rigorous coursework. Dr. Enzinger has two highly qualified and committed mentors: Dr. Deb Schrag, a renowned researcher in cancer care delivery, and Dr. Holly Prigerson, a leader in end-of-life socio-behavioral research. Her advisory panel has deep and varied expertise in health communications, qualitative research, psychometrics, and socio-behavioral interventions. Dr. Enzinger's position as a health services researcher, medical oncologist and palliative care physician at Dana-Farber Cancer Institute likewise offer an ideal environment to support her career. In sum, the proposed research and career development plan will position the candidate to meet her study aims, garner future R01 funding for a definitive study of her intervention, and help launch her career as an independent investigator dedicated to enhancing EOL cancer care by developing and implementing novel communication interventions.