Screening Program for Cancer

Overseen By The 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2067 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a program can increase cancer screenings and follow-ups for breast, cervical, and colorectal cancer among low-income and uninsured women in Central Ohio. The Ohio State University (OSU) SCREEN Community Program includes education and outreach activities to encourage more women to get screened, which can detect cancer early when treatment is more manageable. Women who face challenges accessing regular health care and screenings, particularly those in minority, rural, or low-income communities, might find this trial suitable. As an unphased trial, this study offers participants the chance to contribute to important research that can enhance access to cancer screenings for underserved communities.

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 prior data suggests that the OSU SCREEN Community Program is safe for increasing cancer screening?

Research has shown that the Ohio State University (OSU) SCREEN Community Program aims to increase cancer screenings among underserved women in Ohio. The program employs educational and community-based methods to improve screening rates for breast, cervical, and colorectal cancer.

The program does not involve taking medication or undergoing medical procedures. Instead, it provides support through education, reminders, and community outreach to encourage cancer screening. As a result, there are no known medical risks or side effects from participating.

The Data and Safety Monitoring Plan at OSUCCC – James carefully monitors the program's safety, ensuring participants' well-being in clinical trials. Since the program focuses on education and support, it is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OSU SCREEN Community Program because it aims to enhance cancer screening rates using a comprehensive community and clinic-based approach. Unlike traditional methods that rely heavily on patient initiative and standard reminders, this program integrates community outreach, educational sessions for providers, and personalized patient engagement through electronic health records (EHR) and risk assessments. By actively involving clinic champions and community health workers, the program hopes to overcome barriers to screening and ensure timely follow-up for positive results, potentially leading to earlier detection and better outcomes for breast, cervical, and colorectal cancers.

What evidence suggests that the OSU SCREEN Community Program could be effective for increasing cancer screenings among underserved women?

Research has shown that the OSU SCREEN Community Program, evaluated in this trial, significantly increases cancer screening rates. For instance, rural women are six times more likely to receive timely screenings for breast, cervical, and colorectal cancer when educated remotely. Screening is crucial because it detects early signs of cancer, facilitating easier and more effective treatment. This trial includes various arms, focusing on health clinics, healthcare providers, patients, and community outreach, to assess different strategies for improving access to screenings and increasing rates among underserved communities. These efforts aim to reduce cancer cases and deaths in these groups. ^{6 7 8 9 10}

Who Is on the Research Team?

Electra D. Paskett, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

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

Health care providers and office staff at participating clinics involved in the screening and/or screening referral process must be able to speak, read, and write English

Community residents in targeted census tracts around each clinic are included

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. cancer.osu.edu cancer.osu.edu/news/six-fold-increase-in-rural-cancer-screenings-with-remote-outreach

Six-fold increase in rural cancer screenings with remote ... Rural women are six times more likely to get timely breast, cervical and colorectal cancer screening with remote outreach that involves interactive education ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/550892

The Ohio State University (OSU) SCREEN Community Program Screening can detect precancerous colorectal and cervical lesions and other early-stage cancers when treatment is less intensive and more successful and is ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3895453/

Improving Colorectal Cancer Screening by Using ... The estimated CRC screening rates within guidelines were 55.6% (95% CI, 47.9%, 63.0%) for women receiving the intervention and 49.7% (95% CI, 42.9%, 56.6%) for ...

4. cancer.osu.edu cancer.osu.edu/blog/health-equity-and-cancer-screenings-strategies-for-underserved-communities

Health equity and cancer screenings: strategies for ... Health equity is the goal for an Ohio State expert focused on increasing access to cancer screenings and other needs.

5. cancer.gov cancer.gov/news-events/cancer-currents-blog/2023/improving-cancer-screening-rural-women

Increasing Cancer Screening among Women in Rural US A new study has found an effective way to help women in rural towns get screened for cancer. But the study didn't zero in on just one kind ...

6. cancer.osu.edu cancer.osu.edu/for-cancer-researchers/clinical-research/clinical-research-standards-and-governance/data-safety-monitoring-plan

Data and Safety Monitoring Plan | OSUCCC – James Read about the Data and Safety Monitoring Plan at the OSUCCC – James, in place to ensure the safety of cancer patients participating in clinical trials.

7. withpower.com withpower.com/trial/phase-carcinoma-2-2025-66190

Screening Program for Cancer 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 ...

8. cancer.osu.edu cancer.osu.edu/news/ohio-state-joins-nationwide-effort-to-resume-cancer-screening-treatment

Ohio State Joins Nationwide Effort to Resume Cancer ... The letter examines distressing trends showing a significant drop-off in recommended cancer screening and treatment compared to prior years.

9. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/550892

The Ohio State University (OSU) SCREEN Community Program Screening can detect precancerous colorectal and cervical lesions and other early-stage cancers when treatment is less intensive and more successful and is ...

10. wexnermedical.osu.edu wexnermedical.osu.edu/features/ohio-state-genomic-health/privacy-and-faqs

Ohio State Genomic Health Privacy and FAQs Ohio State Genomic Health Privacy and FAQs. Learn about the Genomic Health program and how we protect your privacy. Sign up for no cost genetic screening.