An Upstream Palliative Care Intervention for Rural Family Caregivers

 描述（由申请人提供）：本K99/R 00申请描述了申请人J. Nicholas Dionne- Odom，PhD，RN的背景和经验，以及他计划获得必要的知识和培训，成为开发和测试远程医疗姑息治疗干预措施的领先独立临床研究者，以优化晚期癌症患者的农村家庭护理人员（FCG）的结局。在K99阶段的总体目标是获得先进的研究培训，制定干预措施，进行随机对照试验（RCT），和健康指导/动机访谈，以开发和测试远程保健计划的农村FCG的晚期癌症的人生活在美国南部。根据Pearlin的家庭照顾模式，这种新的干预措施的目标是通过指导他们如何不仅管理照顾对象的照顾要求和需要，而且管理自己的需要，来提高FCG的自我效能、能力和决策技能。K99阶段的具体培训目标是：（1）制定和调整干预措施，以便：1a）深入了解社区使用混合方法参与研究的情况; 1b）在制定、手册化和评估干预措施的保真度方面发展深入的理解和技能; 1c）深入了解最先进的远程保健和其他移动保健发展;和1d）更好地理解以精神和信仰为导向的干预措施;（2）培养技能， 设计和领导与家庭健康相关的随机对照试验; 3）增加健康指导的知识和技能;（4）继续进行研究伦理培训。K99阶段的研究具体目标是：通过与a）晚期癌症农村居民，B）他们的主要FCG，以及c）非专业保健导航员的访谈，为南方农村晚期癌症患者的FCG制定和定制远程保健干预的内容，格式和交付。为了实现K99的培训目标，我们与一个由高级研究专家组成的跨学科导师和顾问团队合作，制定了一个全面的培训计划。该计划包括密集的一对一指导，正式的课程/研讨会，临床试验研究奖学金和会议出席。R 00阶段的总体目标是对60名南方农村晚期癌症FCG进行试点随机对照试验，以评估K99阶段新定制的FCG干预措施的可接受性、可行性和潜在疗效。R 00阶段的研究具体目标是：1）评价新定制的FCG干预的可接受性以及在FCG干预的RCT中招募和保留60名参与者24周的可行性; 2）评价与常规护理相比，干预在改善护理人员结局（生活质量、负担和情绪[抑郁/焦虑]）方面的疗效。研究结果将直接支持R-01应用程序对晚期癌症患者的农村南部FCG进行早期远程医疗PC干预的疗效RCT。

 DESCRIPTION (provided by applicant): This K99/R00 application describes the background and experience of the applicant, J. Nicholas Dionne- Odom, PhD, RN, and his plan to acquire the knowledge and training necessary to become a leading independent clinical investigator in developing and testing telehealth palliative care interventions that optimize the outcomes of rural family caregivers (FCGs) of persons with advanced cancer. The overall goal during the K99 phase is to gain advanced research training in developing interventions, conducting randomized controlled trials (RCTs), and health coaching/motivational interviewing in order to develop and test a telehealth program for rural FCGs of persons with advanced cancer living in the Southern US. Based on Pearlin's Model of Family Caregiving, the goal of this new intervention will be to promote FCGs' self-efficacy, competence, and decision- making skills by coaching them about how to manage not only the care demands and needs of their care recipients but also their own needs. The specific training objectives during the K99 phase are to: (1) develop and tailor interventions, to: 1a) gain advanced understanding of community engagement in research using mixed methods; 1b) develop advanced understanding and skills in developing, manualizing, and assessing fidelity of an intervention; 1c) gain greater understanding of cutting edge telehealth and other m-health developments; and 1d) develop greater understanding of spiritually- and faith-based-oriented interventions; (2) develop skills to design and lead RCTs relevant to family caregiving; 3) augment knowledge and skills in health coaching; and (4) continue training in research ethics. The research specific aim during the K99 phase is: through interviews with a) rural dwelling persons with advanced cancer, b) their primary FCGs, and c) lay healthcare navigators, develop and tailor the content, format and delivery of a telehealth intervention for FCGs of persons with advanced cancer in the rural South. To meet the K99 training objectives, a comprehensive training plan has been developed in concert with an interdisciplinary mentorship and consultant team of senior research experts. The plan includes intensive one-on-one mentorship, formal coursework/workshops, clinical trial research observerships, and conference attendance. The overall goal during the R00 phase is to conduct a pilot RCT with 60 rural Southern advanced cancer FCGs to assess acceptability, feasibility, and potential efficacy of the newly tailored FCG intervention resulting from the K99 phase. The research specific aims during the R00 phase are to: 1) evaluate the acceptability of a newly tailored FCG intervention and the feasibility of enrolling and retaining 60 participants into a RCT of the FCG intervention for 24 weeks and 2) evaluate the efficacy of the intervention in improving caregiver outcomes (quality of life, burden, and mood [depression/anxiety]) compared to usual care. The results will directly support an R-01 application to conduct an efficacy RCT of an early, telehealth PC intervention for rural Southern FCGs of advanced cancer patients.