Screening Program for Cancer

Overseen by Electra D. Paskett, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Electra D. Paskett, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

The OSU SCREEN Community Program is for low-income and un/underinsured women in Central Ohio. It aims to increase cancer screenings for breast, cervical, and colorectal cancers among those who face higher risks due to minority status, rural location, or economic challenges.

Inclusion Criteria

I receive health care and screenings from my clinic or doctor.

Community residents in targeted census tracts around each clinic are included

Health clinics must provide preventive health care to residents of the targeted census tracts

Treatment Details

Interventions

• The Ohio State University (OSU) SCREEN Community Program (Behavioral Intervention)

Trial Overview This trial tests a multi-level intervention (MLI) that includes patient education at clinics and community strategies like media programs. The goal is to boost screening rates for breast, cervical, and colorectal cancers among underserved populations.

Participant Groups

Group I: Phase III and IV, Arm VI (MLI Delayed Wave) Experimental Treatment 1 Intervention

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

Group II: Phase III and IV, Arm V (MLI Early Wave) Experimental Treatment 1 Intervention

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

Group III: Phase I, Planning Phase (MLI material, focus group, interview) Experimental Treatment 3 Interventions

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.

Group IV: Phase II, Arm I (Health Clinics) Active Control 5 Interventions

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.

Group V: Phase II, Arm II (Health Care Providers) Active Control 5 Interventions

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.

Group VI: Phase II, Arm III (Patients) Active Control 4 Interventions

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.

Group VII: Phase II, Arm IV (Community) Active Control 4 Interventions

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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+