Precision Lung Cancer Survivorship Care Intervention: A Randomized Controlled Trial Serving Rural Survivors and Communities

精准肺癌幸存者护理干预：服务农村幸存者和社区的随机对照试验

• 批准号: 10445228
• 负责人: Jerod Lynn Stapleton
• 金额: $ 59.26万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-06 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10445228
• 关键词: Acute; Address; Advocate; Appalachian Region; Area; Bibliotherapy; Cancer Burden; Cancer Care Facilities; Cancer Etiology; Cancer Survivor; Cancer Survivorship; Caregivers; Caring; Cessation of life; Clinical; Collaborations; Communities; Data; Development; Distress; Early Diagnosis; Early treatment; Economics; Educational Status; Fostering; Foundations; Goals; Guidelines; Health behavior; Health behavior change; Health behavior outcomes; Health care facility; Illness impact; Incidence; Individual; Infrastructure; Intervention; Kentucky; Malignant neoplasm of lung; Measures; Methods; Modeling; Oncology; Outcome; Patient-Centered Care; Play; Population; Poverty; Prevention; Quality of Care; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Research; Role; Rural; Rural Community; Survivors; Symptoms; Thoracic Oncology; Tobacco; Treatment Efficacy; Treatment Side Effects; United States National Institutes of Health; Wages; acceptability and feasibility; base; behavior change; burden of illness; cancer care; care delivery; care outcomes; comparative efficacy; cost effective; cost effectiveness; cost-effectiveness evaluation; experience; feasibility trial; health care availability; implementation design; improved; improved outcome; informal caregiver; innovation; intervention program; lung cancer prevention; mortality; motivational enhancement therapy; novel; optimism; patient engagement; pilot trial; preference; programs; psychologic; psychological distress; psychosocial wellbeing; recruit; rural America; rural area; rural cancer care; screening; shared decision making; social; social stigma; socioeconomic disadvantage; socioeconomics; survivorship; symptom management; symptom treatment; treatment as usual; trial comparing; underserved community

PROJECT SUMMARY Among the devastating illnesses impacting rural America, few exact the physical, social, psychological, and economic toll of lung cancer. Lung cancer is the leading cause of cancer death in rural America, and the levy is particularly acute in Kentucky – a state that not only leads the nation in lung cancer incidence and mortality but is a global epicenter of lung cancer. Despite the prevailing nihilism regarding lung cancer care, lung cancer survivors are living longer. Innovations in prevention, early detection, and treatment, have created substantial optimism and opportunities for long-term lung cancer survivorship. These dramatic changes in the lung cancer care landscape have invigorated the need for quality lung cancer survivorship interventions. The overarching goal of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program is to reduce the burden of lung cancer by offering an innovative survivorship care approach that improves lung cancer quality of life, overcomes lung cancer stigma, and helps survivors engage with care. Using a novel precision survivorship approach and developed in collaboration with rural community stakeholders, the program's foundation incorporates principles of patient-centered care, shared decision making, and motivational interviewing to build survivor engagement. A large acceptability and feasibility trial conducted in collaboration with nine lung cancer care facilities in Kentucky with lung cancer survivors (N=140) demonstrated the acceptability of the intervention among survivors, caregivers, and lung cancer care clinicians. The study also revealed the feasibility of conducting the proposed study methods in rural cancer care facilities. The proposed project continues this program of research by conducting a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program (KLCLCSC) among lung cancer survivors (N=300) against an enhanced usual care condition (bibliotherapy+assessment) on quality of life outcomes. Rural-residing lung cancer survivors will be recruited from ten oncology care facilities throughout Kentucky. The project's first aim compares the efficacy of the interventions with regard to lung cancer quality of life among survivors as measured by the FACT-L and other rigorous assessments of patient engagement, symptom burden, psychosocial well-being, and behavior change. The project's second aim evaluates the moderating impact of including caregivers as intervention partners on survivor quality of life outcomes. A third aim evaluates the cost-effectiveness of the KLCLCSC intervention in comparison to the enhanced usual care condition. Based on highly encouraging pilot data collected in collaboration with oncology care programs in Kentucky, this research holds credible potential to establish a new paradigm for addressing the challenges associated with lung cancer and for delivering quality survivorship care to rural-residing, economically distressed lung cancer survivors.

项目摘要 在影响美国农村的毁灭性疾病中，很少有人能确切地描述身体、社会、心理和 肺癌的经济损失。肺癌是美国农村地区癌症死亡的主要原因， 尤其是在肯塔基州-一个不仅在肺癌发病率和死亡率方面领先全国的州， 是全球肺癌的中心尽管关于肺癌护理普遍存在虚无主义，但肺癌 幸存者活得更长。预防、早期发现和治疗方面的创新， 乐观和长期肺癌生存的机会。肺癌的这些戏剧性变化 护理景观已经阐明了对高质量肺癌生存干预的需求。总体 肯塔基州LEADS协作肺癌生存护理计划的目标是减少 通过提供改善肺癌的创新生存护理方法来减轻肺癌负担 生活质量，克服肺癌的耻辱，并帮助幸存者参与护理。使用一种新 精确的生存方法，并与农村社区利益攸关方合作制定， 该计划的基础包括以病人为中心的护理原则，共同决策， 激励性访谈，以建立幸存者的参与。一项大型可接受性和可行性试验， 与肯塔基州的9家肺癌护理机构合作，治疗肺癌幸存者（N=140）， 幸存者、照顾者和肺癌护理临床医生对干预的可接受性。研究 还揭示了在农村癌症护理设施进行拟议的研究方法的可行性。的 拟议的项目通过进行两组平行随机临床试验继续这项研究计划。 比较肯塔基州LEADS协作肺癌生存护理计划影响的试验 （KLCLCSC）在肺癌幸存者（N=300）中进行增强的常规护理条件 （阅读疗法+评估）对生活质量的影响。农村肺癌幸存者将被招募 来自肯塔基州的十家肿瘤治疗机构。该项目的第一个目标是比较 通过FACT-L和其他方法测量幸存者的肺癌生活质量 严格评估患者参与度、症状负担、心理健康和行为 变化该项目的第二个目标是评估将照顾者作为干预措施的调节作用 幸存者生活质量结果的合作伙伴。第三个目标是评估九龙中柱会的成本效益 与增强的常规护理条件相比，根据非常令人鼓舞的试点数据 这项研究是与肯塔基州的肿瘤护理项目合作收集的， 建立一个新的范例，以应对与肺癌相关的挑战，并提供高质量的 为居住在农村、经济困难的肺癌幸存者提供生存护理。