Grant Number:	1R21CA271070-01A1 Interpret this number
Primary Investigator:	Padamsee, Tasleem
Organization:	Ohio State University
Project Title:	Developing a Patient Navigation Intervention to Improve Risk Management Among Women at High Risk of Breast Cancer
Fiscal Year:	2023

Project Summary/Abstract Women with a family history and/or genetic predisposition for breast cancer (BC) can face significantly elevated lifetime BC risk, but the cancer risk management options (i.e., surveillance routines, preventive surgeries, and medications) that are shown to reduce risk and enable early detection are used by only a small proportion of women for whom they are recommended. There is a critical need to develop evidence-based strategies to improve the standard of care for high-risk women. Population-based screening programs, usually facilitated through screening mammography services, offer significant promise of identifying most high-risk women. Effectively reducing BC morbidity and mortality, however, also requires additional steps to communicate personalized risk information and risk-management options; connect women with healthcare providers capable of explaining risk, its consequences, and risk-management options; support risk-related decision making; and facilitate risk-management decisions and behavior. Prior research has illuminated (a) a staged pathway along which high-risk women adopt risk-management behavior and (b) eight main facilitators (related to information, support, beliefs, access to care, and resolution of practical barriers) that help advance women along the risk-management adoption pathway (R-MAP). In addition, survey-based studies have demonstrated that the majority of high-risk women experience significant gaps in access to these facilitators, and that these gaps are particularly acute among Black women. The goal of the proposed study is to design, develop, and test a multi-dimensional patient navigation (PN) intervention to advance high-risk women along the risk-management adoption pathway by addressing the eight main facilitators of risk-management behavior. Aim 1: Determine the specific information, types of support, barrier reductions, and provider referrals that would advance women at high risk of BC along the pathway toward risk-management adoption, using semi- structured interviews with high-risk Black and White women. Aim 2: Develop a multi-dimensional PN intervention to advance high-risk women along the risk-management adoption pathway, guided by data generated in Aim 1 and a panel composed of experts and patient representatives. Aim 3: Test the feasibility of the PN intervention and of recruiting to a participants to a randomized controlled trial of the intervention. Seventy-five participants identified after a screening mammogram as potentially at high BC risk will be randomized to PN-intervention or information-only conditions in a 2:1 ratio. Baseline surveys and final surveys after eight months will be used to assess the primary hypothesis that most intervention-arm participants will be satisfied with the PN intervention, and to check several other benchmarks of feasibility. We will also descriptively estimate progress along the R-MAP and other outcomes, to appropriately power a randomized controlled trial (RCT) to come. This research will set the stage for a full-scale RCT of this innovative intervention with racially and socioeconomically diverse populations, and ultimately contribute to cancer prevention and control among high-risk women.





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