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

Primary Purpose

Colorectal Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Consultation
Educational Intervention
Electronic Health Record Review
Fecal Immunochemical Test
Feedback
Health Education
Support Education Activity
Text Message-Based Navigation Intervention
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Carcinoma

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: PATIENTS: 50-75 years of age PATIENTS: >= 1 clinic visit/past 2 years

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm II (usual care)

Group I (education, feedback, consult, FIT kit, text message)

Arm Description

Physicians and clinic staff provide and patients recieve CRC screening usual care throughout the trial.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2023
Last Updated
October 13, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Tobacco Related Disease Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT06090643
Brief Title
Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups
Official Title
Implementation Research to Reduce Colorectal Cancer Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Tobacco Related Disease Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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 recieve CRC screening usual care throughout the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm II (usual care)
Arm Type
Active Comparator
Arm Description
Physicians and clinic staff provide and patients recieve CRC screening usual care throughout the trial.
Arm Title
Group I (education, feedback, consult, FIT kit, text message)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Recieve CRC screening usual care
Intervention Type
Other
Intervention Name(s)
Consultation
Other Intervention Name(s)
Consult
Intervention Description
Recieve consultation with clinic staff
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Recieve education and training on CRC screening
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Fecal Immunochemical Test
Other Intervention Name(s)
FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test
Intervention Description
Recieve FIT kit with culturally tailored instructions
Intervention Type
Behavioral
Intervention Name(s)
Feedback
Intervention Description
Recieve feedback on CRC screening
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Recieve CRC screening recommendations
Intervention Type
Other
Intervention Name(s)
Support Education Activity
Intervention Description
Utilize clinical decision support tool
Intervention Type
Other
Intervention Name(s)
Text Message-Based Navigation Intervention
Other Intervention Name(s)
Automated Text Message-Based Navigation, Text Message-Based Navigation
Intervention Description
Recieve text message reminders
Primary Outcome Measure Information:
Title
Colorectal cancer (CRC) screening rate
Description
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.
Time Frame
Up to 3 years
Title
Rate of failure to provide a FIT kit to an eligible patient making a clinic visit
Description
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.
Time Frame
Up to 3 years
Title
Return rate of completed FIT kits
Description
The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: PATIENTS: 50-75 years of age PATIENTS: >= 1 clinic visit/past 2 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roshan Bastani
Phone
310-206-9266
Email
bastani@ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshan Bastani
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roshan Bastani
Phone
310-206-9266
Email
bastani@ucla.edu
First Name & Middle Initial & Last Name & Degree
Roshan Bastani

12. IPD Sharing Statement

Learn more about this trial

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

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