ClinicalTrials.gg
RecruitingNCT07220018Updated Oct 16, 2026

Colorectal Cancer Screening in the Homeless

An interventional study of mHealth for Colorectal cancer screening in Homeless Persons and Control SMS Messages in Colorectal Cancer, sponsored by George Washington University. Recruiting at 1 site in United States. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by George Washington University · Not applicable, Interventional, and Health services research

Updated Oct 16, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
588
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • homeless persons
  • mHealth
  • short message service
  • texting
03

In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 588 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
588 participants (estimated)

Study arms

  • Experimental
    Colorectal Cancer Specific Education

    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

  • Other
    General Health Education

    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

  • BehavioralmHealth for Colorectal cancer screening in Homeless Persons

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

  • OtherControl SMS Messages

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

06

What researchers measure

Primary outcomes

  1. Completion of CRC Screening

    Completed rates of CRC screenings (colonoscopy or FIT test)

    Time frame: 6 months

Secondary outcomes

  1. Perceptions, Attitudes, and Experiences on SMS texts

    Semi-structured Interviews with participants and providers

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 24832144 ↗
  • 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. PubMed 26208591 ↗
  • 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. PubMed 26313765 ↗
  • 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. PubMed 30084381 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Jun 2030, 43 months after the start.

Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 43 months is above that.

Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 16, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2025
First posted
Oct 23, 2025
StartActual
Oct 14, 2026was Sep 2026
Primary completionEst.
Jun 2, 2030
CompletionEst.
Sep 19, 2030
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 21, 2026→Oct 14, 2026 (actual)
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Start date Sep 21, 2026→Oct 14, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07220018
Responsible party
Ramin Asgary (Professor, George Washington University) — Principal investigator
First posted
Oct 23, 2025
Start date
Oct 14, 2026
Primary completion
Jun 2, 2030 (estimated)
Completion
Sep 19, 2030 (estimated)
Last update
Oct 16, 2026

Study contacts

Leah Bauder, MPH
Contact
leahbaud@gwu.edu
202-994-6803
Ramin Asgary, MD, MPH
principal investigator · George Washington University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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