Trial Title:
The Ohio State University (OSU) SCREEN Community Program
NCT ID:
NCT06666192
Condition:
Breast Carcinoma
Cervical Carcinoma
Colorectal Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cancer Screening
Description:
Undergo cancer screening
Arm group label:
Phase II, Arm III (Patients)
Other name:
Cancer Screening for Patients
Other name:
Early Cancer Detection
Other name:
Screening
Other name:
Screening of Cancer
Intervention type:
Other
Intervention name:
Discussion
Description:
Participate in discussions
Arm group label:
Phase II, Arm II (Health Care Providers)
Arm group label:
Phase II, Arm III (Patients)
Arm group label:
Phase II, Arm IV (Community)
Other name:
Discuss
Intervention type:
Other
Intervention name:
Educational Activity
Description:
Receive coaching calls
Arm group label:
Phase II, Arm II (Health Care Providers)
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Receive educational materials
Arm group label:
Phase II, Arm III (Patients)
Arm group label:
Phase II, Arm IV (Community)
Other name:
Education for Intervention
Other name:
Intervention by Education
Other name:
Intervention through Education
Other name:
Intervention, Educational
Intervention type:
Behavioral
Intervention name:
Focus Group
Description:
Participate in focus group
Arm group label:
Phase I, Planning Phase (MLI material, focus group, interview)
Intervention type:
Other
Intervention name:
Health Care Delivery
Description:
Integrate new activities into usual clinic processes
Arm group label:
Phase II, Arm I (Health Clinics)
Arm group label:
Phase II, Arm II (Health Care Providers)
Other name:
Care Delivery
Other name:
Health Services Delivery, Other
Other name:
Healthcare Delivery
Intervention type:
Other
Intervention name:
Health Promotion
Description:
Promote screening and wellness visits
Arm group label:
Phase II, Arm I (Health Clinics)
Other name:
Health Promotion (Salutogenesis)
Other name:
Health Promotion and Wellness
Other name:
Mindfulness Health Promotion
Other name:
Salutogenesis
Intervention type:
Other
Intervention name:
Health Promotion and Education
Description:
Participate in educational sessions
Arm group label:
Phase II, Arm II (Health Care Providers)
Intervention type:
Other
Intervention name:
Health Promotion and Education
Description:
Participate in early wave MLI
Arm group label:
Phase III and IV, Arm V (MLI Early Wave)
Intervention type:
Other
Intervention name:
Health Promotion and Education
Description:
Participate in late wave MLI
Arm group label:
Phase III and IV, Arm VI (MLI Delayed Wave)
Intervention type:
Behavioral
Intervention name:
Health Risk Assessment
Description:
Incorporate risk assessments
Arm group label:
Phase II, Arm I (Health Clinics)
Other name:
Risk Assessment
Intervention type:
Procedure
Intervention name:
Implementation
Description:
Implement MLI
Arm group label:
Phase II, Arm I (Health Clinics)
Intervention type:
Other
Intervention name:
Informational Intervention
Description:
Review MLI materials
Arm group label:
Phase I, Planning Phase (MLI material, focus group, interview)
Intervention type:
Other
Intervention name:
Internet-Based Intervention
Description:
Receive educational online materials
Arm group label:
Phase II, Arm III (Patients)
Intervention type:
Other
Intervention name:
Interview
Description:
Participate in interview
Arm group label:
Phase I, Planning Phase (MLI material, focus group, interview)
Intervention type:
Behavioral
Intervention name:
Outreach
Description:
Receive outreach activities
Arm group label:
Phase II, Arm IV (Community)
Other name:
Outreach Strategy
Intervention type:
Behavioral
Intervention name:
Patient Navigation
Description:
Receive access to CHW
Arm group label:
Phase II, Arm I (Health Clinics)
Arm group label:
Phase II, Arm IV (Community)
Other name:
Patient Navigator Program
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Phase II, Arm II (Health Care Providers)
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.
Criteria for 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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Contact:
Last name:
Electra D. Paskett, PhD
Phone:
614-293-3917
Email:
Electra.Paskett@osumc.edu
Contact backup:
Last name:
Electra D. Paskett
Start date:
March 1, 2025
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06666192
http://cancer.osu.edu
