The Development and Evaluation of a Community-Based, Early Palliative Care Intervention for Black Women with Metastatic Breast Cancer

针对患有转移性乳腺癌的黑人女性的基于社区的早期姑息治疗干预措施的开发和评估

• 批准号: 10351768
• 负责人: Melissa Mazor
• 金额: $ 19.27万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-20 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10351768
• 关键词: Address; Advanced Malignant Neoplasm; Area; Award; Biometry; Cancer Patient; Caring; Chronic; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Communities; Complex; Data; Development; Diagnosis; Discipline of Nursing; Dissemination and Implementation; Distress; Environment; Evaluation; Evidence based intervention; Family; Fatigue; Feedback; Focus Groups; Foundations; Funding; Geriatrics; Goals; Grant; Health Disparities Research; Health Services; Healthcare Systems; Individual; Institutes; Institution; Internal Medicine; Intervention; Knowledge; Latinx population; Leadership; Malignant Neoplasms; Medicine; Melissa; Mentors; Metastatic breast cancer; Methods; Modeling; Morbidity - disease rate; NCI-Designated Cancer Center; Neuropathy; New York City; Not Hispanic or Latino; Nurses; Oncologist; Oncology; Pain; Palliative Care; Palliative Medicine; Patient Care; Patients; Population Heterogeneity; Preparation; Randomized Controlled Trials; Reporting; Research; Research Activity; Research Infrastructure; Research Personnel; Research Support; Rural; Scholarship; Screening for cancer; Self Management; Solid; Symptoms; Testing; Time; Training; Training Activity; Underrepresented Populations; Underserved Population; United States National Institutes of Health; Woman; Writing; attentional control; base; black women; cancer health disparity; care delivery; care outcomes; career development; cognitive interview; community engaged research; community organizations; design; disparities in morbidity; end of life; ethnic diversity; evidence base; experience; health disparity; health equity; improved; improved outcome; innovation; intervention delivery; malignant breast neoplasm; medical schools; minority patient; mortality; multidisciplinary; physical symptom; primary outcome; programs; psychologic; psychological symptom; racial disparity; racial diversity; racial minority; skills; social; social culture; social determinants; social health determinants; symptom management; therapy development; treatment arm

PROJECT SUMMARY/ABSTRACT Research: Early palliative care (PC) for patients with advanced cancer is an understudied area of health equity. Black women with metastatic breast cancer (MBC) disproportionality suffer from the psychological and physical impacts of living with this serious condition. The purpose of this study is to develop and evaluate a community-engaged, lay-navigator (LN) led, early PC intervention (‘ACCEPT-PC’) that targets distress and symptom burden in Black women with MBC. The specific aims are to: 1) Conduct focus groups to assess the early PC needs and preferred content, format, and delivery of a LN led community-based PC intervention; 2) Iteratively develop and refine the ACCEPT-PC intervention; 3) Conduct a pilot randomized controlled trial (RCT) of ACCEPT-PC to determine feasibility, including preliminary impact, in preparation for a fully powered trial. To accomplish these aims, we will employ a sequential embedded, mixed method, community-engaged design. Qualitative findings from focus groups with patients and stakeholders will guide the development of ACCEPT-PC, which will be iteratively refined using cognitive interviews, and evaluated for feasibility and preliminary impact in a pilot RCT. Candidate: The primary objective of this application is to support Dr. Melissa Mazor’s career development from a mentored researcher to an independent nurse-investigator focused on improving disparities in PC for underserved women with advanced cancer. This K08 award will provide her with advanced training in the following four areas: 1) PC intervention development; 2) health disparities research; 3) clinical trial design, leadership and evaluation; and 4) R01 grant writing, leadership, and professional development. To achieve these goals, she has assembled a multidisciplinary mentoring team. Dr. Lin, her primary mentor, is an accomplished clinician-investigator focused on breast cancer self-management. Dr. Wisnivesky, her co-primary mentor, is a disparities health services researcher with formal training in biostatistics. Dr. Smith, an oncologist trained in PC, will provide expertise in community-engaged research and social determinants of PC disparities. Her scientific advisors include Dr. Goldstein, a health services researcher in the area of community-based PC and Dr. Dionne-Odom, a nurse researcher who will provide advanced training in LN coaching for cancer patients and clinical trials. Environment: The Icahn School of Medicine at Mount Sinai has a strong tradition of outstanding research and is one of the top 20 medical schools in NIH funding. The Division of General Internal Medicine is the largest division in the Department of Medicine and has a well-established section of research and exceptional research infrastructure. The Tisch Cancer Institute is an NCI-designated cancer center with well-established research and serves a large population of diverse patients throughout New York City. The Brookdale Department of Geriatrics and Palliative Medicine is one of the leading palliative care institutions with unparalleled research support.

项目总结/摘要 研究：晚期癌症患者的早期姑息治疗（PC）是一个未充分研究的健康领域 股权患有转移性乳腺癌（MBC）的黑人妇女遭受心理和 生活在这种严重的情况下对身体的影响。本研究的目的是开发和评估一种 社区参与、非专业导航员（LN）领导的早期PC干预（“ACCEPT-PC”），针对痛苦和 MBC黑人妇女的症状负担。具体目标是：1）组织焦点小组，评估 早期PC需求和首选内容，形式，以及LN领导的基于社区的PC干预的交付; 2） 反复开发和完善ACCEPT-PC干预; 3）进行试点随机对照试验 (RCT)确定可行性，包括初步影响，以准备一个全面的 审判为了实现这些目标，我们将采用顺序嵌入式混合方法，社区参与 设计来自患者和利益相关者焦点小组的定性结果将指导 ACCEPT-PC，将使用认知访谈进行迭代完善，并评估其可行性和 在试点RCT中的初步影响。候选人：本申请的主要目的是支持梅丽莎博士 Mazor的职业发展从一个指导研究员到一个独立的护士调查员，专注于 改善服务不足的晚期癌症妇女的PC差异。K 08奖将为她提供 在以下四个领域进行高级培训：1）PC干预开发; 2）健康差异研究; 3） 临床试验设计、领导和评估;以及4）R 01资助撰写、领导和专业 发展为了实现这些目标，她组建了一个多学科的指导团队。林医生，她 主要导师，是一个有成就的临床研究者，专注于乳腺癌自我管理。博士 Wisnivesky，她的共同主要导师，是一个不平等的卫生服务研究员与正规培训， 生物统计学史密斯博士是一名接受过PC培训的肿瘤学家，他将提供社区参与研究的专业知识， PC差异的社会决定因素。她的科学顾问包括戈尔茨坦博士， 研究人员在该地区的社区为基础的个人电脑和博士。 为癌症患者和临床试验提供LN指导的高级培训。环境：伊坎学院 医学在西奈山有一个强大的传统，杰出的研究，是前20名的医学之一， 学校在NIH资助。普通内科是内科中最大的部门， 医学，并有一个完善的研究和特殊的研究基础设施部分。悌西 癌症研究所是一个国家癌症研究所指定的癌症中心，具有完善的研究，并为大型 整个纽约市的不同患者群体。布鲁克代尔老年医学系， 姑息医学是领先的姑息治疗机构之一，拥有无与伦比的研究支持。