Grant Number:	1R37CA309199-01A1 Interpret this number
Primary Investigator:	Moss, Jennifer
Organization:	Pennsylvania State Univ Hershey Med Ctr
Project Title:	Improving the Cancer Screening Process: Impact of Self-Sampling Tools Among Underscreened Patients
Fiscal Year:	2026

PROJECT SUMMARY In the US, tens of thousands of people die from screen-preventable cancers each year. Participation in the cancer screening process is suboptimal, and failures occur at each step, from screening initiation, to screening completion (i.e., receipt of a normal screening result or diagnostic resolution after an abnormal result), to repeat screening at recommended intervals. Self-sampling tools are evidence-based modalities that enable patients to collect their own specimen for a cancer screening test (for colorectal cancer: fecal immunochemical tests [FITs]; for cervical cancer: self-sampled human papillomavirus [HPV] tests). These tools bolster cancer screening initiation, but their effects on screening completion and repeat screening are critically understudied. Importantly, behavioral theory suggests that characteristics of self-sampling tools and of patients can influence cancer screening outcomes, and theory further suggests that participation in one screening behavior may increase the likelihood of participating in others. Therefore, we propose a trial to evaluate the impact of self- sampling tools on the entire cancer screening process among patients who are eligible but out-of-date with CRC screening (n=742) and/or cervical cancer screening (n=250). Patients will be randomized (1:1) to receive, by mail, a letter encouraging them to make an appointment to get screened (Usual practice arm) or self- sampling tool(s) for screening (Self-sampling arm); all patients will continue to receive standard of care (including diagnostic resolution, if indicated) from the healthcare system. Additional data will come from patients’ electronic health records and from surveys. Aim 1 will investigate between-arms differences in CRC screening initiation and in cervical cancer screening initiation, within 12 months. Aim 2 will examine between- arms differences in CRC screening completion and in cervical cancer screening completion, within 18 months, as well as 1-year repeat CRC screening with FIT. Aim 3 will identify mediators and moderators that influence the relationship between study arm and cancer screening outcomes. This project is innovative because it represents the first multiple cancer screening trial that includes self-sampled HPV testing, with outcomes across the entire cancer screening process, and it will provide novel insights into hard-to-reach patients who forgo screening initiation, completion, and repeat screening. The project is led by an early-stage investigator and builds upon strong pilot data and the expertise of a transdisciplinary, collaborative study team. The project is responsive to priorities from the National Cancer Institute, Healthy People 2030, the President’s Cancer Panel, and the US Preventive Services Task Force, with significant implications for clinical care, public health, and behavioral research. Anticipated findings can inform innovative and effective strategies to increase participation in the cancer screening process and to reduce avoidable cancer mortality.





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