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Program Official
Principal Investigator
Joshua Brian Demb
Awardee Organization

University Of California, San Diego
United States

Fiscal Year
2025
Activity Code
R00
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

Optimal early colorectal cancer screening initiation

Colorectal cancer (CRC) accounts for 8% of cancer incidence and 9% of cancer-related mortality in the United States (US). About 11% of CRC cases are diagnosed before age 50—known as early age onset CRC (EOCRC)—with incidence and mortality rates increasing 1.6% and 1% per year between 2005-2014, and an unequal burden among Asian, American Indian/Alaska Native, Black and Hispanic racial/ethnic groups and those with Medicaid or uninsured. The increasing EOCRC burden informed a US Preventive Services Task Force (USPSTF) recommendation to initiate CRC screening among average risk adults starting at age 45, rather than 50. This recommendation would expand CRC screening to 21 million Americans, with 4 million more turning 45 each year. There is a lack of evidence to inform how to optimize impact of CRC screening among adults ages 45-49. Specifically, there are three critical knowledge gaps: 1) we lack information regarding acceptability of CRC screening among those ages 45-49 and have not investigated factors that might influence CRC screening uptake among this newly eligible population, 2) there are concerns that CRC screening disparities that exist among adults ages ≥50 are likely to emerge in this younger age group without a targeted screening strategy and 3) it is unclear whether this age group will respond to current CRC screening practice or more active outreach. The central objective of this proposal is to develop a targeted CRC screening strategy among adults ages 45-49 to maximize screening uptake and prevent cancer disparities. Our study will recruit adults ages 45-49 receiving care within a large health system to answer these questions. First, we will characterize the acceptability of CRC screening by running a pilot trial to establish feasibility of a larger trial (Aim 1a) and conduct surveys and interviews regarding factors influencing CRC screening uptake (Aim 1b) to highlight effective strategies for implementing screening among adults ages 45-49. Next, we will use these pilot data to inform a randomized controlled trial of the comparative effectiveness of an active outreach strategy including mailed fecal immunochemical test versus usual care for optimizing uptake and preventing emergence of CRC screening disparities (Aim 2). This research plan is complemented by a training plan to enhance the applicant’s background in epidemiology and biostatistics, with new training in 1) randomized controlled trials methodology, 2) health behavior and medical decision making research, 3) health equity and disparities research and 4) survey and qualitative research methods. Our study will be the most comprehensive examination of early CRC screening initiation in the US to date and will provide context to the updated CRC screening policy and a potential framework for wider implementation of earlier CRC screening in adults ages 45-49. It also offers a high-quality career development opportunity to develop key skills to become a qualified independent investigator.

Clinical Trials

Study Name Clinical Trial ID
Head to Head Trial of Mailed Cologuard to Mailed FIT NCT06931860