NCT07220018

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
588

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
52mo left

Started Jul 2026

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

3.9 years

First QC Date

October 21, 2025

Last Update Submit

October 24, 2025

Conditions

Keywords

homeless personsmHealthshort message servicetexting

Outcome Measures

Primary Outcomes (1)

  • Completion of CRC Screening

    Completed rates of CRC screenings (colonoscopy or FIT test)

    6 months

Secondary Outcomes (1)

  • Perceptions, Attitudes, and Experiences on SMS texts

    6 months

Study Arms (2)

Colorectal Cancer Specific Education

EXPERIMENTAL

6 months of mHealth Colorectal cancer educational messages. The content will address elements such as activating and educating patients, exploring and removing challenges, accommodating personal goals, and engaging and targeting subgroups. Texts will be delivered to encourage cancer screenings and lifestyle changes, and participants will receive appointment reminders before each appointment with a follow-up text and robocall if the appointment is missed.

Behavioral: mHealth for Colorectal cancer screening in Homeless Persons

General Health Education

OTHER

6 months of mHealth, including basic healthcare and general health promotion via SMS texts that do not overlap with CRC screening content.

Other: Control SMS Messages

Interventions

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

Colorectal Cancer Specific Education

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

General Health Education

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University

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

Location

Related Publications (4)

  • Asgary R, Garland V, Jakubowski A, Sckell B. Colorectal cancer screening among the homeless population of New York City shelter-based clinics. Am J Public Health. 2014 Jul;104(7):1307-13. doi: 10.2105/AJPH.2013.301792. Epub 2014 May 15.

    PMID: 24832144BACKGROUND
  • Asgary R, Sckell B, Alcabes A, Naderi R, Ogedegbe G. Perspectives of cancer and cancer screening among homeless adults of New York City shelter-based clinics: a qualitative approach. Cancer Causes Control. 2015 Oct;26(10):1429-38. doi: 10.1007/s10552-015-0634-0. Epub 2015 Jul 25.

    PMID: 26208591BACKGROUND
  • Asgary R, Sckell B, Alcabes A, Naderi R, Adongo P, Ogedegbe G. Perceptions, Attitudes, and Experience Regarding mHealth Among Homeless Persons in New York City Shelters. J Health Commun. 2015;20(12):1473-80. doi: 10.1080/10810730.2015.1033117. Epub 2015 Aug 27.

    PMID: 26313765BACKGROUND
  • Asgary R. Cancer screening in the homeless population. Lancet Oncol. 2018 Jul;19(7):e344-e350. doi: 10.1016/S1470-2045(18)30200-6. Epub 2018 Jun 29.

    PMID: 30084381BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Ramin Asgary, MD, MPH

    George Washington University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Bauder, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Data analyst
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized clinical trial evaluating an intervention against a control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2025

First Posted

October 23, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

October 28, 2025

Record last verified: 2025-10

Locations