Grant Number:	1R01CA301168-01 Interpret this number
Primary Investigator:	O'Neill, Suzanne
Organization:	Georgetown University
Project Title:	Bundled Multicancer Screening and Genetic Services Navigation to Improve Cancer Outcomes
Fiscal Year:	2025

Despite effective interventions, >65,000 women die each year of breast and colorectal cancer. A disproportionate number of these deaths occur among women facing challenges in the receipt of evidence-based care such as cancer screening and genetic testing. Addressing these challenges at the patient and organizational level could improve outcomes. Aligning community-based navigation with the healthcare system can increase rates of screening and testing, allowing for referral to care. Delivering multicancer screening, risk assessment and testing in navigation programs in parallel or sequentially via bundling of services could efficiently address primary and secondary prevention of multiple cancers with less burden to patients and systems. Our pilot work demonstrates that multicancer screening navigation and familial cancer risk assessment protocols are feasible and can increase rates of colorectal cancer screening in systems that successfully navigate women to breast cancer screening. Despite these promising findings, the intensity, complexity, and content of bundling might decrease feasibility, acceptability and/or effectiveness of individual interventions. Therefore, we now must test the protocol in a fully-powered trial in generalizable settings as well as test methods that can increase lagging rates of genetic testing among those referred in this program. We will test the bundling of multicancer prevention services in two breast cancer screening navigation programs aligned with NCI-recognized Comprehensive and Community Cancer Centers. Women will receive familial cancer risk assessment at intake and be randomized to multicancer (colorectal + breast) vs. single (breast) cancer navigation, using a wait list control for colorectal cancer screening referral and navigation, stratified by site and genetics referral eligibility. Participants will be women aged 45-74 who are due for breast and colorectal cancer screening and referred to cancer screening navigation programs that are based in communities with low screening and testing rates. Primary analyses will be conducted among those not referred to genetics (N=600) to test effectiveness for colorectal cancer screening and non-inferiority for breast cancer screening (Aim 1) as well as effect modifiers (Aim 2). We will conduct exploratory subanalyses among those referred to genetic counseling to test the effect of bundling screening (multicancer vs. single cancer) and genetic services (usual care referral vs. print pre-counseling education + usual care referral; N=180; Aim 4). We will conduct a multisite mixed-methods organization- and patient-focused process evaluation, guided by the Consolidated Framework for Implementation Research (Aim 3). Our expert team will move the field forward by testing innovative, multilevel intervention methods to test solution-oriented delivery strategies that improve cancer outcomes.