CClinicalTrials.gg
Active, not recruitingNCT06090643Updated Nov 14, 2025

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

An interventional study of Best Practice and Consultation in Colorectal Carcinoma, sponsored by Jonsson Comprehensive Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-14.

Sponsored by Jonsson Comprehensive Cancer Center · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Nov 2019, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
9,745
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Carcinoma
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 9,745 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • PATIENTS: 50-75 years of age
  • PATIENTS: >= 1 clinic visit/past 2 years
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9,745 participants (actual)

Study arms

  • Active comparator
    Arm II (usual care)

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

    Other: Best Practice · Other: Electronic Health Record Review

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

    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.

    Other: Consultation · Other: Educational Intervention · Other: Electronic Health Record Review · Other: Fecal Immunochemical Test · Behavioral: Feedback · Behavioral: Health Education · Other: Support Education Activity · Other: Text Message-Based Navigation Intervention

Interventions

  • OtherBest Practice

    Receive CRC screening usual care

    Also known as: standard of care, standard therapy

  • OtherConsultation

    Receive consultation with clinic staff

    Also known as: Consult

  • OtherEducational Intervention

    Receive education and training on CRC screening

    Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

  • OtherElectronic Health Record Review

    Ancillary studies

  • OtherFecal Immunochemical Test

    Receive FIT kit with culturally tailored instructions

    Also known as: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test

  • BehavioralFeedback

    Receive feedback on CRC screening

  • BehavioralHealth Education

    Receive CRC screening recommendations

  • OtherSupport Education Activity

    Utilize clinical decision support tool

  • OtherText Message-Based Navigation Intervention

    Receive text message reminders

    Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 3 years

  2. 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.

    Time frame: Up to 3 years

  3. 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.

    Time frame: Up to 3 years

07

Study locations

1 site
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06090643
Lead sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Tobacco Related Disease Research Program
Responsible party
Sponsor
First posted
Oct 19, 2023
Start date
Nov 1, 2019
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Nov 14, 2025

Study contacts

Roshan Bastani
principal investigator · UCLA / Jonsson Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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