The Ohio State University (OSU) SCREEN Community Program

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06666192
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Cancer Screening — OTHER
    Undergo cancer screening
  • Discussion — OTHER
    Participate in discussions
  • Educational Activity — OTHER
    Receive coaching calls
  • Educational Intervention — OTHER
    Receive educational materials
  • Focus Group — BEHAVIORAL
    Participate in focus group
  • Health Care Delivery — OTHER
    Integrate new activities into usual clinic processes
  • Health Promotion — OTHER
    Promote screening and wellness visits
  • Health Promotion and Education — OTHER
    Participate in educational sessions
  • Health Promotion and Education — OTHER
    Participate in early wave MLI
  • Health Promotion and Education — OTHER
    Participate in late wave MLI
  • Health Risk Assessment — BEHAVIORAL
    Incorporate risk assessments
  • Implementation — PROCEDURE
    Implement MLI
  • Informational Intervention — OTHER
    Review MLI materials
  • Internet-Based Intervention — OTHER
    Receive educational online materials
  • Interview — OTHER
    Participate in interview
  • Outreach — BEHAVIORAL
    Receive outreach activities
  • Patient Navigation — BEHAVIORAL
    Receive access to CHW
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Mar 12, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
2,067 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING

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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Electra D. Paskett, PhD
[email protected]
614-293-3917
Electra D. Paskett (PRINCIPAL_INVESTIGATOR)

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By specialty
OncologyBreast oncologyWomen's healthGynecologic oncologyGI oncology
By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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