Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity

Not Applicable

Recruiting

• Conditions: Colorectal Cancer

• 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

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