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Compensation: Varies

Number of Visits: Unknown

2067 Participants Needed

Screening Program for Cancer

Overseen ByThe Ohio State University Comprehensive Cancer Center

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: None specified

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment The Ohio State University (OSU) SCREEN Community Program for cancer screening?

The effectiveness of cancer screening programs, like the OSU SCREEN Community Program, is supported by research showing that organized screening can reduce cancer deaths by finding cancers early when they are more treatable. Successful programs are those that achieve high participation and follow-up, as seen in breast and cervical cancer screenings, which have been demonstrated to be effective.¹ ² ³ ⁴ ⁵

Is the cancer screening program generally safe for humans?

The safety of cancer screening programs, like the one described, is generally supported by studies showing benefits in early detection and survival rates. However, potential harms can occur, mainly related to follow-up procedures after abnormal screening results, but these are typically outweighed by the benefits of early cancer detection.¹ ⁶ ⁷ ⁸ ⁹

How does the OSU SCREEN Community Program treatment differ from other cancer screening treatments?

The OSU SCREEN Community Program is unique because it focuses on early detection of cancer by targeting specific demographic and epidemiological groups, providing health education, and ensuring follow-up for diagnosis and treatment. This approach aims to increase participation and effectiveness by tailoring the program to the needs of the community and integrating it into a comprehensive healthcare system.¹ ² ⁶ ¹⁰ ¹¹

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

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Timeline

Planning

Providers and community members review MLI materials and participate in focus groups and interviews to discuss challenges to being screened.

1 year

Pilot

Pilot test and refine the MLI planning and implementation process in one clinic.

2 years

Implementation

Test the final MLI planning and implementation process in a group randomized, delayed intervention trial.

2 years

Sustainability Assessment

Assess sustainability of the MLI.

1 year

Follow-up

Participants are monitored for the effectiveness of the intervention and follow-up for abnormal tests.

4 years

Treatment Details

Interventions

The Ohio State University (OSU) SCREEN Community Program

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

7Treatment groups

Experimental Treatment

Active Control

Group I: Phase III and IV, Arm VI (MLI Delayed Wave)Experimental Treatment1 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 Treatment1 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 Treatment3 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 Control5 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 Control5 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 Control4 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 Control4 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.

Find a Clinic Near You

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+

Findings from Research

Effective cancer screening relies on well-defined criteria and organized systems to identify individuals with hidden diseases, which can lead to reduced morbidity and mortality.

Successful screening programs require high participation rates, quality control, and ongoing evaluation to maximize their potential benefits; without proper organization, the effectiveness of screening may be compromised.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of successful cancer screening.Smith, RA.[2016]

A community-based lung cancer CT screening program significantly improved 5-year survival rates to 64% compared to only 19% in nonscreened patients, demonstrating the effectiveness of early detection in improving outcomes.

The program identified lung cancer at earlier stages (I or II) in 75% of cases, indicating that CT screening can benefit even those who do not meet the high-risk criteria established by the National Lung Screening Trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Multidisciplinary Computed Tomography Screening Program Improves Lung Cancer Survival.Miller, DL., Mayfield, WR., Luu, TD., et al.[2022]

In a study of 11,520 individuals aged 55 to 80 who underwent lung cancer screening with low-dose CT (LDCT), the rates of follow-up imaging and procedures were found to be low, with 17.7% requiring imaging and only 3.1% undergoing procedures within 12 months.

The adjusted rates of specific follow-up procedures were also low, with bronchoscopy at 2.0% and percutaneous biopsy at 1.3%, indicating that while LDCT screening is beneficial, it does not lead to excessive follow-up interventions in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Imaging and Diagnostic Procedures After Low-Dose CT Screening for Lung Cancer.Nishi, SPE., Zhou, J., Okereke, I., et al.[2023]