Clinical trial NCT06666192: The Ohio State University (OSU) SCREEN Community Program
Official title: A Multi-Level Intervention for Improving Screening Rates of Breast, Cervical and Colorectal Cancer in Women in Low-Income Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Cervical Carcinoma
Colorectal Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2024-10-30
Enrollment: 2067
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

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.

Detailed description: PRIMARY OBJECTIVES:

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Up to date (UTD) status for all three screenings (Early Intervention Wave)
timeFrame: At baseline and at the end of the Implementation Phase (up to 4 years)
measure: Status of follow-up for abnormal tests (Early Intervention Wave)
timeFrame: At baseline and at the end of the Implementation Phase (up to 4 years)
Secondary outcomes:
measure: UTD screening status for all three cancers and follow up rates for abnormal tests
timeFrame: At the end of early intervention (up to 2.5 years)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Electra D Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References: