Multi-site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers

针对肺癌护理人员的 CONNECT 干预措施的多站点社区肿瘤学规划

• 批准号: 10730680
• 负责人: Chandylen Lenae Nightingale
• 金额: $ 28.37万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10730680
• 关键词: Academic Medical Centers; Address; Anxiety; Caregiver Burden; Caregiver research; Caregivers; Caring; Clinic; Collaborations; Communication; Communities; Community Clinical Oncology Program; Control Groups; Data; Data Collection; Databases; Enrollment; Ensure; Equity; Evaluation; Family; Frequencies; Future; Goals; Human Resources; Intervention; Investigation; Link; Lung; Malignant neoplasm of lung; Medical; Mental Depression; Methods; Modality; Oncology; Outpatients; Patients; Persons; Phase; Process; Protocols documentation; Psychosocial Assessment and Care; Quality of Care; Randomized; Reporting; Research; Research Design; Resources; Rural; Self Care; Services; Site; Supportive care; Surveys; Testing; Time; Training; Translating; Update; acceptability and feasibility; arm; base; cancer care; cancer therapy; care delivery; care recipients; care systems; caregiver interventions; clinically significant; community setting; comparison group; design; efficacy evaluation; efficacy testing; efficacy trial; empowerment; ethnic minority; evidence base; experience; forest; group intervention; health care service utilization; improved; improved outcome; informal support; innovation; interest; intervention delivery; minority patient; novel; outpatient programs; phase III trial; pilot test; pilot trial; preference; primary outcome; programs; racial minority; randomized, clinical trials; recruit; secondary outcome; standard care; success; tool; trial enrollment; trial planning; web-based intervention; willingness

Project Summary Our team has demonstrated availability of evidence-based supportive care services in community oncology to support informal (unpaid/ family) caregivers in caring for themselves and their care recipient undergoing cancer treatment (e.g., psychosocial support, self-care/ wellness classes, medical task training), but connection to these services is abysmal. A scalable and systematic process is critically needed to identify caregiver needs and connect caregivers with services. This may be especially valuable for lung cancer caregivers who report exceptional supportive care needs and high levels of caregiver burden. We previously demonstrated strong feasibility and acceptability of Caregiver Oncology Needs Evaluation Tool (CONNECT) in a pilot randomized clinical trial with 40 lung cancer caregivers at one academic medical center. We also observed significant improvements in caregiver burden and a clinically significant decrease in depression in the intervention group relative to control group. We propose in this next step of multi-site intervention planning, to also include navigation to address barriers that may hamper caregiver supportive care use. The overall goal of this program of research is to develop innovative and scalable programs to improve supportive care delivery for cancer caregivers in the community. In this application, we propose to gather essential data for a future multi-site efficacy trial of CONNECT in collaboration with the Wake Forest NCI Community Oncology Research Program Research Base (WF NCORP RB) and key stakeholders. For Aim 1, we will survey NCORP sites to determine outpatient oncology practice (N=60) interest and capacity to test the CONNECT Intervention across the broad NCORP network. For Aim 2 and Aim 3, we will conduct a multi-site randomized pilot trial. For Aim 2, we will assess the multi-site feasibility (accrual, participation, and retention) of the CONNECT Intervention enrolling 120 lung cancer caregiver-patient dyads (CONNECT, n=40; Standard Care, n=40; Generic Resource List, n=40) with the goal of informing methods for the future trial. For Aim 3, we will obtain preliminary data on site training needs, time needed for site participation, and communication processes between participating sites and study personnel to optimize multi-site intervention delivery in the future fully powered trial. Pending demonstration of feasibility, we will conduct a future fully powered efficacy trial using the NCORP network.

项目摘要 我们的团队已经证明了社区肿瘤学中循证支持性护理服务的可用性， 支持非正式（无薪/家庭）照顾者照顾自己和他们的照顾者患有癌症 治疗（例如，社会心理支持，自我护理/健康课程，医疗任务培训），但与 这些服务是糟糕透顶的。迫切需要一个可扩展和系统化的过程来确定护理人员的需求 并将护理人员与服务联系起来。这可能是特别有价值的肺癌照顾者谁报告说， 特殊的支持性护理需求和高水平的照顾者负担。我们之前展示了强大的 在一项试点随机化研究中， 在一个学术医疗中心对40名肺癌护理人员进行的临床试验。我们还观察到显著的 干预组的照顾者负担有所改善，抑郁症有临床意义的减少 相对于对照组。我们建议在多站点干预计划的下一步中，还包括 导航以解决可能妨碍护理人员使用支持性护理的障碍。该计划的总体目标是 研究的重点是开发创新和可扩展的计划，以改善癌症的支持性护理 社区中的照顾者。在这个应用程序中，我们建议收集必要的数据，为未来的多站点 与维克森林NCI社区肿瘤学研究项目合作进行的一项关于抗肿瘤ECT的疗效试验 研究基地（WF NCORP RB）和主要利益相关者。对于目标1，我们将调查NCORP站点，以确定 门诊肿瘤实践（N=60）的兴趣和能力，以测试广泛的抗肿瘤治疗干预 NCORP网络对于目标2和目标3，我们将进行一项多中心随机初步试验。目标2： 评估多中心参与的可行性（招募、参与和保留） 120例肺癌患者-患者配对（THEECT，n=40;标准护理，n=40;通用资源列表， n=40），目的是为未来的试验提供信息。至于目的3，我们会实地取得初步数据， 培训需求、研究中心参与所需的时间以及参与研究中心之间的沟通过程 和研究人员，以便在未来的全功率试验中优化多部位干预输送。未决 为了证明可行性，我们将使用NCORP网络进行未来的全功率功效试验。