Recruiting

Observational Study

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06666192

Conditions

Breast Carcinoma

Cervical Carcinoma

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Cancer Screening

Discussion

Educational Activity

Educational Intervention

Focus Group

Study Details

Brief summary:

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.

Conditions

Breast Carcinoma

Cervical Carcinoma

Colorectal Carcinoma

Study ID

NCT06666192

Start date

Mar 12, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2067 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Phase I, Planning Phase (MLI material, focus group, interview)

Providers and community members review MLI materials and participate in focus groups and interviews to discuss challenges to being screened, what community members know about cancer and screening and what should be included in a program to increase screening over 30-60 minutes on study. A clinic champion will be identified during the interview to lead, advise, and oversee the implementation of the MLI at their clinic location.

active comparator: Phase II, Arm I (Health Clinics)

The clinic champion coordinates planning sessions, staff training, and overall implementation and planning for the MLI within each health clinic. Health clinics may integrate new activities into usual clinic processes such as the use of the EHR to identify age-eligible patients in need of breast, cervical and/or CRC screening, reminder systems built into the EHR that can be sent to both providers and patients for screening and follow-up, and EHR information alerts for providers about patients who have positive FITs or a positive Pap test or mammogram on study. Additionally, health clinics may incorporate risk assessments (via paper or within the EHR) for all patients eligible for breast, cervical and/or CRC screening, promote screening via web-based or health portal messaging, promote annual wellness visits (during which screening should be discussed), and offer incentives for completing needed cancer screening on study.

active comparator: Phase II, Arm II (Health Care Providers)

Providers participate in educational sessions that include self-administered pre-test surveys and discussions that assess screening knowledge, beliefs, attitudes, and practices, over one hour on study. Providers may also undergo coaching calls and one-on-one discussions to help tailor information and its delivery to the needs of providers and practices and are taught how to use clinic-based scheduling and reminder systems to help facilitate screening and follow-up actions.

active comparator: Phase II, Arm III (Patients)

Patients receive educational materials about screening and screening recommendations via mail and during in-person visits, and a web link for the developed small media website on study. Patients participate in discussions about screening and are offered any test for which they are not up to date and appropriate follow-up is conducted by designated staff on study. Patients who choose to undergo testing and receive a positive result receive a letter from the clinic and a call from the designated clinic staff member on study.

active comparator: Phase II, Arm IV (Community)

Community receive educational materials (e.g., posters) and outreach activities to promote screening (e.g., health fairs, farmers' markets, inflatable colon tours, community seminars) and receive access to a CHW for one-on-one education about screening on study.

experimental: Phase III and IV, Arm V (MLI Early Wave)

Participating clinics and communities participate in the MLI early (years 2-3) for up to 30 months.

experimental: Phase III and IV, Arm VI (MLI Delayed Wave)

Participating clinics and communities participate in the MLI 12 months later (years 3-4) for at least 12 months.

Interventions

Cancer Screening

Undergo cancer screening

Discussion

Participate in discussions

Educational Activity

Receive coaching calls

Educational Intervention

Receive educational materials

Focus Group

Participate in focus group

Health Care Delivery

Integrate new activities into usual clinic processes

Health Promotion

Promote screening and wellness visits

Health Promotion and Education

Participate in educational sessions

Health Promotion and Education

Participate in early wave MLI

Health Promotion and Education

Participate in late wave MLI

Health Risk Assessment

Incorporate risk assessments

Implementation

Implement MLI

Informational Intervention

Review MLI materials

Internet-Based Intervention

Receive educational online materials

Interview

Participate in interview

Outreach

Receive outreach activities

Patient Navigation

Receive access to CHW

Survey Administration

Ancillary studies

Primary outcome measure

  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Electra D. Paskett, PhD

614-293-3917Electra.Paskett@osumc.edu

Principal Investigator:

Electra D. Paskett

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2025-12-24.