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NCT Number: NCT07220018

Colorectal Cancer Screening in the Homeless

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location contact

Ramin Asgary, MD, MPH

CONTACT

[email protected]

202-994-6803

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mHealth for Colorectal cancer screening in Homeless Persons

Behavioral

Specific colorectal cancer educational SMS text messages are sent to participants' mobile phones

Control SMS Messages

Other

Standard health information SMS text messages sent to participants' mobile phones

Primary outcomes

  1. Completion of CRC Screening

    Time frame: 6 months

    Completed rates of CRC screenings (colonoscopy or FIT test)

Secondary outcomes

  1. Perceptions, Attitudes, and Experiences on SMS texts

    Time frame: 6 months

    Semi-structured Interviews with participants and providers

Study contacts

Contact information is provided by the study sponsor or research team.

Leah Bauder, MPH

CONTACT

[email protected]

202-994-6803

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

mHealth Navigation Using SMS Texting to Improve CRC Screening Among Homeless Persons

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 23, 2025
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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