Trial Title:
Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups
NCT ID:
NCT06090643
Condition:
Colorectal Carcinoma
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive CRC screening usual care
Arm group label:
Arm II (usual care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Consultation
Description:
Receive consultation with clinic staff
Arm group label:
Group I (education, feedback, consult, FIT kit, text message)
Other name:
Consult
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Receive education and training on CRC screening
Arm group label:
Group I (education, feedback, consult, FIT kit, text message)
Other name:
Education for Intervention
Other name:
Intervention by Education
Other name:
Intervention through Education
Other name:
Intervention, Educational
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Arm II (usual care)
Arm group label:
Group I (education, feedback, consult, FIT kit, text message)
Intervention type:
Other
Intervention name:
Fecal Immunochemical Test
Description:
Receive FIT kit with culturally tailored instructions
Arm group label:
Group I (education, feedback, consult, FIT kit, text message)
Other name:
FIT
Other name:
iFOBT
Other name:
immunoassay fecal occult blood test
Other name:
immunochemical fecal occult blood test
Other name:
Immunochemical FOBT
Other name:
immunologic fecal occult blood test
Intervention type:
Behavioral
Intervention name:
Feedback
Description:
Receive feedback on CRC screening
Arm group label:
Group I (education, feedback, consult, FIT kit, text message)
Intervention type:
Behavioral
Intervention name:
Health Education
Description:
Receive CRC screening recommendations
Arm group label:
Group I (education, feedback, consult, FIT kit, text message)
Intervention type:
Other
Intervention name:
Support Education Activity
Description:
Utilize clinical decision support tool
Arm group label:
Group I (education, feedback, consult, FIT kit, text message)
Intervention type:
Other
Intervention name:
Text Message-Based Navigation Intervention
Description:
Receive text message reminders
Arm group label:
Group I (education, feedback, consult, FIT kit, text message)
Other name:
Automated Text Message-Based Navigation
Other name:
Text Message-Based Navigation
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.
Detailed 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 receive CRC screening
usual care throughout the trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- PATIENTS: 50-75 years of age
- PATIENTS: >= 1 clinic visit/past 2 years
Gender:
All
Minimum age:
50 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Start date:
November 1, 2019
Completion date:
November 1, 2026
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Tobacco Related Disease Research Program
Agency class:
Other
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06090643
