Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Video text message; Behavioral: In-clinic CRC screening promotion; Behavioral: Reminders; Behavioral: Mailed FIT; Behavioral: Social needs navigation

• Registration Number: NCT06542835
• Lead Sponsor: University of Arizona

Brief Summary

Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.

Detailed Description

The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among predominantly Latinx populations by using video text messages, mailed FIT kits, and patient navigation. The study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. The hypothesis is that a multi-component intervention will increase CRC screening rates and follow-up care, reducing disparities in CRC outcomes.

Study Timeline

• Study First Submitted: 2024-07-19
• Study Start: 2024-07-31
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Ages 45-64
• Eligible for colorectal cancer (CRC) screening
• Current patients (seen in the clinic in the last 6 months)
• Primary speaker of English or Spanish
• Cell phone listed in Electronic Health Record (EHR)
• No recent history of CRC screening
• Resides in one of the neighborhoods included in the main trial

Exclusion Criteria

• Colorectal disease (e.g., ulcerative colitis or colectomy)
• Personal history of colorectal cancer
• End-stage or life-threatening diseases
• Known to be under hospice care
• Living in a skilled nursing facility
• Patients who decline research participation will be removed from the patient contact list

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Video text message, mailed FIT, and social needs navigation	Video text message	Tailored video text message, mailed FIT, and navigation to address patients' social needs.
Video text message, mailed FIT, and social needs navigation	Social needs navigation	Tailored video text message, mailed FIT, and navigation to address patients' social needs.
Usual care	Reminders	Colorectal cancer (CRC) screening offers during in-person clinic visits.
Video text message, mailed FIT, and social needs navigation	Mailed FIT	Tailored video text message, mailed FIT, and navigation to address patients' social needs.
Usual care	In-clinic CRC screening promotion	Colorectal cancer (CRC) screening offers during in-person clinic visits.

Primary Outcome Measures

Name	Time	Method
CRC Screening Completion at the Individual Level	6 months	Measure the completion rate of colorectal cancer (CRC) screening at the individual level within 6 months of receiving the intervention. This will compare the proportion of participants in the post-intervention group versus the pre-intervention group.

Secondary Outcome Measures

Name	Time	Method
FIT completion	6 months	Measure the completion rate of fecal immunochemical tests (FIT) within 6 months of receiving the intervention. This will compare the proportion of participants who complete FIT in the post-intervention group versus the pre-intervention group.
Rate of Follow-Up Colonoscopy Completion	12 months	Track the completion rate of follow-up colonoscopy within 12 months for participants with abnormal FIT results, comparing the post-intervention versus pre-intervention groups.
Time to follow-up colonoscopy	Within 12 months post abnormal FIT result	Measure the time from abnormal FIT result to the completion of follow-up colonoscopy, comparing the post-intervention versus the pre-intervention groups.

Trial Locations

Locations (1)

AltaMed Health Services Corporation; 🇺🇸 Los Angeles, California, United States