Colorectal Cancer Screening in the Homeless

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT07220018
• Lead Sponsor: George Washington University

Brief Summary

This study is designed to assess the effect of implementing a text messaging strategy for colorectal cancer screening among homeless persons aged 45-75 years, who are not up to date on colorectal cancer screening, in shelter clinics in NYC. This mixed-methods study uses a randomized clinical trial design and semi-structured interviews.

Detailed Description

This study seeks to evaluate the extent to which an SMS text-based patient navigation will mitigate some of the barriers to and improve CRC screening in homeless persons. It will include processes customized to the homeless specific needs via a streamlined approach of an SMS text-based navigation in shelters clinics to explain cancer risks and screening options, provide test instructions and support, identify and resolve challenges to screening, respond to questions and concerns, make appointments for screening, support screening completion, provide post-screen counselling, and obtain test results to complete screening loop. The target population will be homeless persons aged 45-75, not up-to-date with CRC screening, recruited from shelter clinics of a community organization serving homeless persons in New York City (NYC). The specific aims of this mixed methods study are:

AIM 1: To evaluate the effect of 6-month SMS text-based patient navigation for CRC screening (INT) versus an attention control (CL) of general health promotion on the completion rates of CRC screening using a randomized trial design in shelter clinics. Hypothesis 1) among homeless persons aged 45-75 not up-to-date with CRC screening, those randomized to the INT (n=294) will have higher CRC screening rates in the magnitude of 10 percentage points, compared to those randomized to the CL (n=294) at 6 months post enrollment. Individual-level randomization will be employed in shelter clinics in NYC.

AIM 2: To evaluate perceptions, attitudes, and experiences of homeless persons (n=50) and providers and staff (n=20) on SMS text navigation for CRC screening in shelter clinics using semi-structured interviews. The results will strengthen the SMS navigation approach by revealing barriers and necessary adaptation needs.

AIM 3: To evaluate perceptions and attitudes of program staff (n=20) of agencies servicing homeless persons in NYC and on the national level on challenges and opportunities of implementing SMS text navigation for cancer care and control in the shelter system using semi-structured interviews.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-21
• Study First Submitted QC: 2025-10-21
• Study First Posted: 2025-10-23
• Last Update Submitted: 2025-10-24
• Last Update Posted: 2025-10-28
• Study Start: 2026-07-01
• Primary Completion: 2030-06
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 588

Inclusion Criteria

• Homeless persons aged 45 - 75 years old, with no up-to-date colorectal cancer screening defined as: 1) no colonoscopy in the past 10 years, or 2) no Flexible sigmoidoscopy, Digital Contrast Barium Enema, or CT colonoscopy in the past 5 years, or 3) no Fecal Immunochemical Test/Fecal Occult Blood in the past 12 months or mt-sDNA/Cologuard Test in the past three years
• English or Spanish speaking
• currently presenting to the shelter clinics for medical care
• connected to multidisciplinary social and health services in NYC shelter clinics

Exclusion Criteria

• known active/uncontrolled illness rendering homeless persons to undergo screening, CRC in the past 2 years, colectomy, Inflammatory Bowel Dis., Familial Adenomatous Polyposis or other colorectal diseases in which screening is different from average CRC risk and methods, inability to consent, serious/significant comorbidity where life expectancy is limited or screening is not recommended, which will be verified by their respective provider
• inability to read and respond to SMS texts
• any condition preventing participants from providing informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Completion of CRC Screening	6 months	Completed rates of CRC screenings (colonoscopy or FIT test)

Secondary Outcome Measures

Name	Time	Method
Perceptions, Attitudes, and Experiences on SMS texts	6 months	Semi-structured Interviews with participants and providers

Trial Locations

Locations (1)

George Washington University; 🇺🇸 Washington D.C., District of Columbia, United States