An interventional study of Standard Screening Outreach and Self-Sampling Outreach Package in Colorectal Cancer Screening and Cervical Cancer Screening, sponsored by Milton S. Hershey Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Screening
This randomized controlled trial will evaluate whether evidence-based self-sampling tools improve the cancer screening process among underscreened patients. Participants who are eligible but out-of-date for colorectal cancer screening, cervical cancer screening, or both will be randomized to either usual practice or an intervention that includes mailed self-sampling tools for the appropriate cancer screening test. Primary outcomes include screening initiation (within 12 months of enrollment) and screening completion (within 18 months of enrollment), for each cancer type. Secondary outcomes include repeat screening adherence and receipt of diagnostic resolution following abnormal screening results.
In the US, tens of thousands of people die from screen-preventable cancers each year. Failures occur across the entire cancer screening process, from screening initiation, to screening completion (i.e., receipt of a normal screening result or diagnostic resolution after an abnormal result), to repeat screening. Providing patients with self-sampling tools can improve these outcomes. These self-sampling tools (fecal immunochemical test [FIT] for colorectal cancer [CRC] screening and self-collected human papillomavirus [HPV] test for cervical cancer screening) enable patients to collect a sample at home and send it to a lab for testing. These tests are highly accurate and acceptable but not well-integrated into clinical care. Further, their impacts on screening completion and repeat screening are not well-studied. The proposed study is a rigorous, two-arm, parallel-groups randomized controlled trial to assess screening initiation, screening completion, and repeat screening among patients who are eligible but out-of-date with screening for CRC and/or cervical cancer. The study team will generate a census of patients in our healthcare system who meet study inclusion criteria and undertake stratified random selection to select patients for inclusion in the study. Patients will be randomized (1:1) to study arm: Usual practice arm, in which patients receive a letter informing them that they are out-of-date with cancer screening and encouraging them to make an appointment to get screened, and Self-sampling arm, in which patients receive self-sampling tool(s) and are encouraged to use it for cancer screening. As appropriate, patients will receive screening reminders, diagnostic resolution follow-up procedures, and 1-year repeat FIT for CRC screening. The study team will collect data from electronic health records and surveys. The study Aims are as follows:
Aim 1: Investigate between-arms differences in screening initiation. Aim 2: Examine between-arms differences in downstream screening outcomes. Aim 3: Identify mediators and moderators that impact the cancer screening process.
The recruitment goal for this study is 852 patients, including 542 who are eligible but out-of-date for CRC screening; 110 who are eligible but out-of-date for cervical cancer screening; and 200 who are eligible but out-of-date for both screenings. This sample will support rigorous, well-powered analyses of our Aims and hypotheses, using bivariate and multivariable analyses (including mediation and moderation analysis). This study will demonstrate the impact of self-sampling tools for the entire cancer screening process, which has significant implications for clinical care, public health, and behavioral research. The findings from the proposed study will support our long-term goal of identifying strategies to increase participation in the cancer screening process and to reduce screen-preventable cancer mortality in the US.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 852 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
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Exclusion Criteria:
Participants will receive standard health system outreach (i.e., mailed reminders) encouraging completion of recommended colorectal and/or cervical cancer screening through routine clinical care pathways.
Behavioral: Standard Screening Outreach
Participants will receive a package containing self-sampling tool(s) for colorectal and/or cervical cancer screening, encouraging them to complete screening with the self-sampling tool.
Behavioral: Self-Sampling Outreach Package
Routine mailed reminders and health system communication encouraging completion of guideline-recommended cancer screening.
Education materials, instructions, and support documents accompanying mailed self-sampling kits.
Colorectal cancer screening initiation
The percentage of patients in each study arm who initiate colorectal cancer screening between baseline and 12-months follow-up, according to electronic health record data.
Time frame: 12 months after baseline
Cervical cancer screening initiation
The percentage of patients in each study arm who initiate cervical cancer screening between baseline and 12-months follow-up, according to electronic health record data.
Time frame: 12 months after baseline
Colorectal cancer screening completion
The percentage of patients in each study arm who complete colorectal cancer screening (i.e., receipt of a normal screening result or diagnostic resolution after an abnormal result) between baseline and 18-months follow-up, according to electronic health record data.
Time frame: 18 months after baseline
Cervical cancer screening completion
The percentage of patients in each study arm who complete cervical cancer screening (i.e., the receipt of a normal screening result or diagnostic resolution after an abnormal result) between baseline and 18-months follow-up, according to electronic health record data.
Time frame: 18 months after baseline
Repeat colorectal cancer screening
Among patients who undergo colorectal cancer screening with FIT and receive normal test results, the percentage of patients who repeat colorectal cancer screening with FIT one year later, within 24 months of baseline, according to electronic health record data.
Time frame: 24 months after baseline
Receipt of diagnostic resolution after abnormal cancer screening results
Among patients who undertake cancer screening and receive abnormal test results, the percentage of patients who receive diagnostic resolution procedures within 6 months of the test results, according to electronic health record data.
Time frame: 6 months after initiating cancer screening
Plan to share: Yes — The study team will make scientific data and associated documentation publicly available through an institutional repository upon study completion. Deidentified participant-level data supporting published findings may be shared upon reasonable request, subject to institutional approvals and applicable data use agreements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning six months after final data collection, with no end date.
Access criteria: Deidentified data and supporting information will be available to anyone through a publicly accessible, online data repository.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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