SCREEN Yourself for Cancer

SCREEN Yourself for Cancer (Self-Collection Research Examining Engagement and Navigation)

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 Participants who are eligible but out-of-date for colorectal cancer screening, cervical cancer screening, or both will be randomized to either usual practice or an intervention that includes mailed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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer Screening; Colorectal Cancer Screening
• Intervention / Treatment: Behavioral: Standard Screening Outreach; Behavioral: Self-Sampling Outreach Package

Detailed Description

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trial to assess screening initiation, screening completion, and repeat screening among patients who are eligible but out-of-date with screening for CRC and/or cervical cancer.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be randomized (1:1) to study arm: Usual practice arm, in which patients receive a letter informing them that they are out-of-date with cancer screening and encouraging them to make an appointment to get screened, and Self-sampling arm, in which patients receive self-sampling tool(s) and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.

• Study Type: Interventional
• Enrollment (Estimated): 852
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonard A. Kishel, MA; Phone Number: 321657 717-531-0003; Email: lkishel@pennstatehealth.psu.edu
• Study Contact Backup: Name: Jennifer L. Moss, PhD; Phone Number: 323429 717-531-0003; Email: jmoss1@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Pennsylvania State University College of Medicine
      • Contact: Leonard A Kishel, MA; Phone Number: 321657 7175310003; Email: lkishel@pennstatehealth.psu.edu
      • Contact: Jennifer L Moss, PhD; Phone Number: 323429 7175310003; Email: jmoss1@pennstatehealth.psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• active patient at Penn State Health Department of Family and Community Medicine
• patients eligible but out-of-date for routine colorectal cancer screening and/or routine cervical cancer screening
• able to read and write in English, Spanish, or Nepali

Exclusion Criteria:

• patients ineligible for routine colorectal and/or cervical cancer screening
• patients up-to-date on routine colorectal and/or cervical cancer screening (as applicable)
• not able to read and write in English, Spanish, or Nepali

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Practice; 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; Routine mailed reminders and health system communication encouraging completion of guideline-recommended cancer screening.
Experimental: Self-sampling arm; 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; Education materials, instructions, and support documents accompanying mailed self-sampling kits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	18 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months after initiating cancer screening

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jennifer L. Moss, PhD, Pennsylvania State University College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 4, 2026
• First Submitted That Met QC Criteria: November 4, 2026
• First Posted (Actual): November 10, 2026

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: implementation science; colorectal cancer screening; cancer screening; cervical cancer screening; preventive medicine; Diffusion of Innovations; screening uptake; HPV self-sampling; FIT testing
• Other Study ID Numbers: STUDY00029563; 1R37CA309199-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning six months after final data collection, with no end date.

IPD Sharing Access Criteria

Deidentified data and supporting information will be available to anyone through a publicly accessible, online data repository.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No