Colorectal CancerNCT07220018
Colorectal Cancer Screening in the Homeless
A study testing mHealth for Colorectal cancer screening in Homeless Persons in people with Colorectal Cancer, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- mHealth for Colorectal cancer screening in Homeless Persons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2026to 19 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
George Washington University
Washington D.C., District of Columbia, 20052
Ramin Asgary, MD, MPH, 202-994-6803, raminasgary1@gwu.edu
About this study
Official title: mHealth Navigation Using SMS Texting to Improve CRC Screening Among Homeless Persons
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.
- Conditions
- Colorectal Cancer
- Being tested
- mHealth for Colorectal cancer screening in Homeless Persons, Control SMS Messages
- Keywords
- homeless persons, mHealth, short message service, texting
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth for Colorectal cancer screening in Homeless PersonsBehavioural
Specific colorectal cancer educational SMS text messages are sent to participants' mobile phones
Control SMS MessagesOther
Standard health information SMS text messages sent to participants' mobile phones
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control SMS Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of CRC Screening
Completed rates of CRC screenings (colonoscopy or FIT test)
Measured: 6 months
Secondary outcomes (1)
Perceptions, Attitudes, and Experiences on SMS texts
Semi-structured Interviews with participants and providers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start14 Oct 2026
- Primary completion2 Jun 2030 (estimated)
- Study completion19 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial evaluating an intervention against a control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Ramin Asgary, George Washington University
- Investigators
- Ramin Asgary, MD, MPH, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220018
- Sponsor's protocol ID
- NCR235230
- Other IDs
- R01MD019112
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 24832144Asgary 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 26208591Asgary 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 26313765Asgary 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Navigation Using SMS Texting to Improve CRC Screening Among Homeless Persons
- ClinicalTrials.gov ID
- NCT07220018
- Acronym / sponsor ID
- NCR235230
- Conditions
- Colorectal Cancer
- Keywords
- homeless persons, mHealth, short message service, texting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 14 Oct 2026 (actual)
- Primary completion
- 2 Jun 2030 (estimated)
- Study completion
- 19 Sep 2030 (estimated)
- First posted
- 23 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial evaluating an intervention against a control
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Specific Education | Experimental | Behavioral: mHealth for Colorectal cancer screening in Homeless Persons6 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. |
| General Health Education | Other | Other: Control SMS Messages6 months of mHealth, including basic healthcare and general health promotion via SMS texts that do not overlap with CRC screening content. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth for Colorectal cancer screening in Homeless PersonsSpecific colorectal cancer educational SMS text messages are sent to participants' mobile phones | Behavioural | Colorectal Cancer Specific Education |
| Control SMS MessagesStandard health information SMS text messages sent to participants' mobile phones | Other | General Health Education |
Primary outcome
Completion of CRC Screening
Time frame: 6 months
Completed rates of CRC screenings (colonoscopy or FIT test)
1 secondary outcome
Perceptions, Attitudes, and Experiences on SMS texts
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 24832144Asgary 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.
- Background: PubMed 26208591Asgary 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.
- Background: PubMed 26313765Asgary 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.
- Background: PubMed 30084381Asgary 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramin Asgary, MD, MPH principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth for Colorectal cancer screening in Homeless Persons in people with Colorectal Cancer, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leah Bauder, MPH (202-994-6803, leahbaud@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of CRC Screening (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07220018, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.