The Ohio State University (OSU) SCREEN Community Program
NCT ID: NCT06666192
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2067 participants
INTERVENTIONAL
2024-03-12
2029-12-31
Brief Summary
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Detailed Description
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I. Understand local factors and context relevant to breast, cervical and CRC screening and follow-up (including referral-to-care) and develop an MLI planning and implementation pathway for use by partner health centers and communities (Year 1).
II. Pilot test and further refine the MLI planning and implementation process in one clinic (Years 1 \& 2).
III. Test the final MLI planning and implementation process in a group randomized, delayed intervention trial to assess the impact of the customized MLI on increasing rates of guideline recommended breast, cervical and CRC screening and follow-up for abnormal tests (Years 2, 3 and 4).
IV. Assess sustainability of the MLI (Years 4 and 5).
OUTLINE:
PHASE I (PLANNING): 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.
PHASE II (PILOT): Participants are assigned to 1 of 4 arms.
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 electronic health record (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 fecal immunochemical test (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.
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.
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.
ARM IV (COMMUNITY): Communities 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 community health worker (CHW) for one-on-one education about screening on study.
PHASE III and IV: Participating clinics and surrounding communities are randomized to 1 of 2 arms.
ARM V (EARLY INTERVENTION WAVE): Participating clinics and communities participate in the MLI early (years 2-3) for up to 30 months.
ARM VI (DELAYED INTERVENTION WAVE): Participating clinics and communities participate in the MLI 12 months later (years 3-4) for at least 12 months.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SCREENING
NONE
Study Groups
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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.
Focus Group
Participate in focus group
Informational Intervention
Review MLI materials
Interview
Participate in interview
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.
Health Care Delivery
Integrate new activities into usual clinic processes
Health Promotion
Promote screening and wellness visits
Health Risk Assessment
Incorporate risk assessments
Implementation
Implement MLI
Patient Navigation
Receive access to CHW
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.
Discussion
Participate in discussions
Educational Activity
Receive coaching calls
Health Care Delivery
Integrate new activities into usual clinic processes
Health Promotion and Education
Participate in educational sessions
Survey Administration
Ancillary studies
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.
Cancer Screening
Undergo cancer screening
Discussion
Participate in discussions
Educational Intervention
Receive educational materials
Internet-Based Intervention
Receive educational online materials
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.
Discussion
Participate in discussions
Educational Intervention
Receive educational materials
Outreach
Receive outreach activities
Patient Navigation
Receive access to CHW
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.
Health Promotion and Education
Participate in early wave MLI
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.
Health Promotion and Education
Participate in late wave MLI
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
ALL
Yes
Sponsors
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American Cancer Society, Inc.
OTHER
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Electra Paskett
Principal Investigator
Principal Investigators
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Electra D Paskett, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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The Ohio State University Comprehensive Cancer Center
Role: CONTACT
Phone: 800-293-5066
Email: [email protected]
Facility Contacts
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Electra D. Paskett, PhD
Role: primary
Related Links
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The Jamesline
Other Identifiers
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NCI-2024-07400
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-23400
Identifier Type: -
Identifier Source: org_study_id