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

NCT ID: NCT06090643

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

9745 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2027-11-01

Brief Summary

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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

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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.

Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Arm II (usual care)

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

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive CRC screening usual care

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Consultation

Intervention Type OTHER

Receive consultation with clinic staff

Educational Intervention

Intervention Type OTHER

Receive education and training on CRC screening

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Fecal Immunochemical Test

Intervention Type OTHER

Receive FIT kit with culturally tailored instructions

Feedback

Intervention Type BEHAVIORAL

Receive feedback on CRC screening

Health Education

Intervention Type BEHAVIORAL

Receive CRC screening recommendations

Support Education Activity

Intervention Type OTHER

Utilize clinical decision support tool

Text Message-Based Navigation Intervention

Intervention Type OTHER

Receive text message reminders

Interventions

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Best Practice

Receive CRC screening usual care

Intervention Type OTHER

Consultation

Receive consultation with clinic staff

Intervention Type OTHER

Educational Intervention

Receive education and training on CRC screening

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Fecal Immunochemical Test

Receive FIT kit with culturally tailored instructions

Intervention Type OTHER

Feedback

Receive feedback on CRC screening

Intervention Type BEHAVIORAL

Health Education

Receive CRC screening recommendations

Intervention Type BEHAVIORAL

Support Education Activity

Utilize clinical decision support tool

Intervention Type OTHER

Text Message-Based Navigation Intervention

Receive text message reminders

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Consult Education for Intervention Intervention by Education Intervention through Education Intervention, Educational FIT iFOBT immunoassay fecal occult blood test immunochemical fecal occult blood test Immunochemical FOBT immunologic fecal occult blood test Automated Text Message-Based Navigation Text Message-Based Navigation

Eligibility Criteria

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Inclusion Criteria

* PATIENTS: 50-75 years of age
* PATIENTS: \>= 1 clinic visit/past 2 years
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tobacco Related Disease Research Program

OTHER

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roshan Bastani

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2022-07503

Identifier Type: REGISTRY

Identifier Source: secondary_id

18-001069

Identifier Type: -

Identifier Source: org_study_id