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

Jonsson Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Colorectal Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06090643

NCI-2022-07503 (Registry Identifier)

18-001069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,745 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,745 participants in 2 patient groups

Arm II (usual care)

Active Comparator group

Description:

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

Treatment:

Other: Electronic Health Record Review

Other: Best Practice

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

Experimental group

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.

Treatment:

Other: Consultation

Other: Educational Intervention

Behavioral: Feedback

Other: Text Message-Based Navigation Intervention

Other: Electronic Health Record Review

Other: Support Education Activity

Behavioral: Health Education

Other: Fecal Immunochemical Test