NCT06666192 · Ohio State University Comprehensive Cancer Center
The Ohio State University (OSU) SCREEN Community Program
What this study is about
This clinical trial develops and tests how well a multi-level intervention (MLI), The Ohio State University (OSU) SCREEN Community Program, works to increase screening and follow-up for breast, cervical and colorectal (CRC) cancer among low-income and un/underinsured female residents in three counties in Central Ohio.
View original scientific description
This clinical trial develops and tests how well a multi-level intervention (MLI), The Ohio State University (OSU) SCREEN Community Program, works to increase screening and follow-up for breast, cervical and colorectal (CRC) cancer among low-income and un/underinsured female residents in three counties in Central Ohio. In Ohio, incidence and mortality rates for breast, cervical and CRC are higher than or similar to the national average; in addition, underserved populations - minority, rural and low-income women - have higher rates of these cancers. Screening can detect precancerous colorectal and cervical lesions and other early-stage cancers when treatment is less intensive and more successful and is known to reduce mortality rates for breast, cervical, and CRC, however many of these women lack access to health care and screenings. This MLI includes clinic-based components, such as patient education, as well as community-based strategies, such as media programs and training health workers, that can increase rates of guideline-recommended breast, cervical and CRC screening and follow-ups in underserved populations. The OSU SCREEN Community Program may be an effective way to improve breast, cervical and CRC screenings among underserved women in Ohio.
Interventions
OTHER
Cancer Screening
Undergo cancer screening
OTHER
Discussion
Participate in discussions
OTHER
Educational Activity
Receive coaching calls
OTHER
Educational Intervention
Receive educational materials
BEHAVIORAL
Focus Group
Participate in focus group
OTHER
Health Care Delivery
Integrate new activities into usual clinic processes
OTHER
Health Promotion
Promote screening and wellness visits
OTHER
Health Promotion and Education
Participate in educational sessions
OTHER
Health Promotion and Education
Participate in early wave MLI
OTHER
Health Promotion and Education
Participate in late wave MLI
BEHAVIORAL
Health Risk Assessment
Incorporate risk assessments
PROCEDURE
Implementation
Implement MLI
OTHER
Informational Intervention
Review MLI materials
OTHER
Internet-Based Intervention
Receive educational online materials
OTHER
Interview
Participate in interview
BEHAVIORAL
Outreach
Receive outreach activities
BEHAVIORAL
Patient Navigation
Receive access to CHW
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
Up to date (UTD) status for all three screenings (Early Intervention Wave)
Time frame: At baseline and at the end of the Implementation Phase (up to 4 years)
Will be assessed by the difference in proportions of being UTD with all age-appropriate screening tests using electronic health record (EHR) data. Rates will be examined by age, race/ethnicity, residence, payer status, provider, time since last visit, and rates of other cancer screening. Repeated measure Generalized Estimating Equations (GEE) models with compound symmetry correlation structure and robust variance will be used to compare change between the early and delayed intervention groups adjusting for baseline UTD screening rates of the targeted communities. Adjustment for baseline UTD screening rates and rates of follow up for abnormal test will control for any differences by intervention group due to chance and will increase power by decreasing the standard error of the treatment effect. To account for differences in number of respondents across targeted communities, GEE models will be weighted using an approach described by Johnson et al.
Status of follow-up for abnormal tests (Early Intervention Wave)
Time frame: At baseline and at the end of the Implementation Phase (up to 4 years)
Will be assessed by the difference in follow-up rates for abnormal tests using EHR data. GEE models with compound symmetry correlation structure and robust variance will be used to compare change between the early and delayed intervention groups adjusting for baseline UTD screening rates of the targeted communities. Adjustment for baseline UTD screening rates and rates of follow up for abnormal test will control for any differences by intervention group due to chance and will increase power by decreasing the standard error of the treatment effect. To account for differences in number of respondents across targeted communities, GEE models will be weighted using an approach described by Johnson et al.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Level 1 is the health clinics (Helping Hands \[pilot\]; 6 Lower Lights clinics). Clinics are eligible if they provide preventive health care to residents of the targeted census tracts.
- Level 2 focuses on health care providers (physicians, nurses, physician assistants \[PA\]/nurse practitioners \[NPs\]) and office staff practicing at participating clinics who are involved in the screening and/or screening referral process (determined by individual clinical sites) and can speak, read, and write English
- Patients (Level 3) are the recipients of health care and screening interventional strategies implemented by clinics and providers.
- Level 4 is the community to include residents in targeted census tracts around each clinic.
Where
- Columbus, Ohio
Collaborators
American Cancer Society, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations