Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups
Implementation Research to Reduce Colorectal Cancer Disparities
2 other identifiers
interventional
9,745
1 country
1
Brief Summary
This clinical trial implements research strategies to increase colorectal cancer (CRC) screening rates among low income and ethnic minority groups. CRC is the second most common cause of cancer mortality in the United States and disproportionately burdens low income and ethnic minority groups. Fecal immunochemical testing (FIT) is a test to check for blood in the stool. A brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. The samples are then sent to a laboratory, where they are checked for a human blood protein. Blood in the stool may be a sign of colorectal cancer. Despite its potential for reducing CRC incidence and mortality, screening remains woefully underutilized. There is an unmet need for practical and effective programs to improve CRC screening rates. By implementing a culturally-tailored screening CRC program that supports providers and clinic staff to encourage eligible patients to complete FIT, researchers hope to reduce cancer disparities among low-income and ethnic groups and increase the CRC screening rate, which will help providers find CRC sooner, when it may be easier to treat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 13, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
November 14, 2025
November 1, 2025
7 years
October 13, 2023
November 12, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Colorectal cancer (CRC) screening rate
Patient-level study data on the primary outcome of CRC screening receipt will be assessed through electronic health record data systems. Fecal immunochemical test (FIT) is the screening method most commonly utilized in NEVHC. Patients who have completed a FIT within the past 12 months will be considered screened. Consistent with current CRC screening guidelines, patients screened via a flexible sigmoidoscopy in the past five years (very rare) or colonoscopy (very small numbers) in the past ten years will also be considered screened. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
Up to 3 years
Rate of failure to provide a FIT kit to an eligible patient making a clinic visit
Missed opportunity rates will be calculated at baseline, end of study, and intermediate time points by determining the number of eligible patients who made a clinic visit but did not receive a FIT kit. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
Up to 3 years
Return rate of completed FIT kits
The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
Up to 3 years
Study Arms (2)
Arm II (usual care)
ACTIVE COMPARATORPhysicians and clinic staff provide and patients receive CRC screening usual care throughout the trial.
Group I (education, feedback, consult, FIT kit, text message)
EXPERIMENTALPhysicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial.
Interventions
Receive CRC screening usual care
Receive consultation with clinic staff
Receive education and training on CRC screening
Ancillary studies
Receive FIT kit with culturally tailored instructions
Receive feedback on CRC screening
Receive CRC screening recommendations
Utilize clinical decision support tool
Receive text message reminders
Eligibility Criteria
You may qualify if:
- PATIENTS: 50-75 years of age
- PATIENTS: \>= 1 clinic visit/past 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roshan Bastani
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2023
First Posted
October 19, 2023
Study Start
November 1, 2019
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2027
Last Updated
November 14, 2025
Record last verified: 2025-11