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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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