The Ohio State University (OSU) SCREEN Community Program

NCT06666192 | Recruiting DMC

• 2 other identifiers: OSU-23400NCI-2024-07400
• Study Type: interventional
• Target: 2,067
• Locations: 1 country
• Sites: 1

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

Colorectal Carcinoma; Breast Carcinoma; Cervical Carcinoma

Outcome Measures

Primary Outcomes (2)

• Up to date (UTD) status for all three screenings (Early Intervention Wave)

  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.

  At baseline and at the end of the Implementation Phase (up to 4 years)

• Status of follow-up for abnormal tests (Early Intervention Wave)

  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.

  At baseline and at the end of the Implementation Phase (up to 4 years)

Secondary Outcomes (1)

• UTD screening status for all three cancers and follow up rates for abnormal tests

  At the end of early intervention (up to 2.5 years)

Study Arms (7)

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

OTHER

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.

Behavioral: Focus Group; Other: Informational Intervention; Other: Interview

Phase II, Arm I (Health Clinics)

ACTIVE COMPARATOR

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.

Other: Health Care Delivery; Other: Health Promotion; Behavioral: Health Risk Assessment; Procedure: Implementation; Behavioral: Patient Navigation

Phase II, Arm II (Health Care Providers)

ACTIVE COMPARATOR

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.

Other: Discussion; Other: Educational Activity; Other: Health Care Delivery; Other: Health Promotion and Education; Other: Survey Administration

Phase II, Arm III (Patients)

ACTIVE COMPARATOR

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.

Other: Cancer Screening; Other: Discussion; Other: Educational Intervention; Other: Internet-Based Intervention

Phase II, Arm IV (Community)

ACTIVE COMPARATOR

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.

Other: Discussion; Other: Educational Intervention; Behavioral: Outreach; Behavioral: Patient Navigation

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

EXPERIMENTAL

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

Other: Health Promotion and Education

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

EXPERIMENTAL

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

Other: Health Promotion and Education

Interventions

Implementation PROCEDURE

Implement MLI

Phase II, Arm I (Health Clinics)

Informational Intervention OTHER

Review MLI materials

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

Internet-Based Intervention OTHER

Receive educational online materials

Phase II, Arm III (Patients)

Outreach BEHAVIORAL

Receive outreach activities

Also known as: Outreach Strategy

Phase II, Arm IV (Community)

Patient Navigation BEHAVIORAL

Receive access to CHW

Also known as: Patient Navigator Program

Phase II, Arm I (Health Clinics); Phase II, Arm IV (Community)

Survey Administration OTHER

Ancillary studies

Phase II, Arm II (Health Care Providers)

Cancer Screening OTHER

Undergo cancer screening

Also known as: Cancer Screening for Patients, Early Cancer Detection, Screening, Screening of Cancer

Phase II, Arm III (Patients)

Interview OTHER

Participate in interview

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

Discussion OTHER

Participate in discussions

Also known as: Discuss

Phase II, Arm II (Health Care Providers); Phase II, Arm III (Patients); Phase II, Arm IV (Community)

Educational Activity OTHER

Receive coaching calls

Phase II, Arm II (Health Care Providers)

Educational Intervention OTHER

Receive educational materials

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Phase II, Arm III (Patients); Phase II, Arm IV (Community)

Focus Group BEHAVIORAL

Participate in focus group

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

Health Care Delivery OTHER

Integrate new activities into usual clinic processes

Also known as: Care Delivery, Health Services Delivery, Other, Healthcare Delivery

Phase II, Arm I (Health Clinics); Phase II, Arm II (Health Care Providers)

Health Promotion OTHER

Promote screening and wellness visits

Also known as: Health Promotion (Salutogenesis), Health Promotion and Wellness, Mindfulness Health Promotion, Salutogenesis

Phase II, Arm I (Health Clinics)

Health Promotion and Education OTHER

Participate in educational sessions

Phase II, Arm II (Health Care Providers)

Health Risk Assessment BEHAVIORAL

Incorporate risk assessments

Also known as: Risk Assessment

Phase II, Arm I (Health Clinics)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms; Colorectal Neoplasms

Interventions

Mass Screening; Early Intervention, Educational; Educational Status; Methods; Focus Groups; Delivery of Health Care; Health Promotion; Risk Assessment; Interviews as Topic; Community-Institutional Relations; Patient Navigation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Child Health Services; Community Health Services; Socioeconomic Factors; Population Characteristics; Patient Care Management; Health Services Administration; Health Education; Risk; Probability; Statistics as Topic; Risk Management; Organization and Administration; Epidemiologic Measurements; Public Relations; Patient-Centered Care; Primary Health Care; Comprehensive Health Care

Study Officials

• Electra D Paskett, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)