The Development and Evaluation of a Community-Based, Early Palliative Care Intervention for Black Women with Metastatic Breast Cancer - Research: Early palliative care (PC) for patients with advanced cancer is an understudied area of health outcomes research. Patients 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 patient-engaged, lay-navigator (LN) led, early PC intervention ('ACCEPT-PC') that targets distress and symptom burden in patients 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 patient-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, patient-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 medically-vulnerable patients 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 patient-engaged research and social determinants of PC disparities. Her scientific advisors include Dr. Goldstein, a health services researcher in the area of patient-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 patients with varied backgrounds throughout New York City. The Brookdale Department of Geriatrics and Palliative Medicine is one of the leading palliative care institutions with unparalleled research support.
