Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups

Colorectal Carcinoma Clinical Trial

Official title:

Implementation Research to Reduce Colorectal Cancer Disparities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090643
• Other study ID #: 18-001069
• Secondary ID: NCI-2022-07503
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 1, 2025

Study information

• Verified date: July 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: Roshan Bastani
• Phone: 310-206-9266
• Email: bastani[@]ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE:

I. To increase CRC screening rates within Northeast Valley Health Corporation (NEVHC).

OUTLINE: Clinic sites are randomized to 1 of 2 groups.

GROUP I CLINICS: Physicians 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.

GROUP II CLINICS: Physicians and clinic staff provide and patients recieve CRC screening usual care throughout the trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• PATIENTS: 50-75 years of age

• PATIENTS: >= 1 clinic visit/past 2 years

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Best Practice
Recieve CRC screening usual care
• Consultation
Recieve consultation with clinic staff
• Educational Intervention
Recieve education and training on CRC screening
• Electronic Health Record Review
Ancillary studies
• Fecal Immunochemical Test
Recieve FIT kit with culturally tailored instructions

Behavioral:
• Feedback
Recieve feedback on CRC screening
• Health Education
Recieve CRC screening recommendations

Other:
• Support Education Activity
Utilize clinical decision support tool
• Text Message-Based Navigation Intervention
Recieve text message reminders

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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