Colo-rectal CancerNCT07345676
Colorectal Cancer Screening Outreach
A study testing Bundled messaging intervention in people with Colo-rectal Cancer, run by Yale University at 1 site in United States.
Trial summary
This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Bundled messaging intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to Jul 2027
- 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
- Established adult medicine patient at Cornell Scott Hill health (defined as having a CSHH primary care doctor or >1 adult medicine visits in the last year).
- Incomplete colorectal cancer screening test defined as an outstanding order for colonoscopy or stool-based CRC screening (e.g., fecal immunochemical test (FIT) or FIT-DNA testing), but no evidence of test completion at the time of randomization. Orders must have been placed between 90-365 days prior to randomization.
- OR
- Abnormal stool-based test without follow-up, defined as an abnormal stool-based test result (e.g., positive FIT or FIT-DNA) with no completed diagnostic colonoscopy within 90 days of the result. Patients who meet this criterion will be included in a non randomized arm of the study.
Who cannot join
- Because this is a pragmatic study of a behavioral intervention to improve colorectal cancer screening adherence, any participants who otherwise meet the inclusion criteria will not be excluded.
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
Cornell Scott Hill Health
New Haven, Connecticut, 06519
About this study
Official title: Optimizing Evidence-Based Interventions to Improve Colorectal Cancer Screening Adherence in Community Health Clinics
This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.
- Conditions
- Colo-rectal Cancer
- Being tested
- Bundled messaging intervention
- Keywords
- Screening adherence
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundled messaging interventionBehavioural
A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary.
| Study group | Role | What they receive |
|---|---|---|
| Control-Usual Care | No intervention | Participants will receive a simple text message reminder |
| Messaging Group A | Experimental | Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C). Receives: Behavioral: Bundled messaging intervention |
| Messaging Group B | Experimental | Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C). Receives: Behavioral: Bundled messaging intervention |
| Messaging Group C | Experimental | Participants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C). Receives: Behavioral: Bundled messaging intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with scheduled or completed colorectal cancer screening.
Number of participants who completed or scheduled screening (colonoscopy or stool-based test) within 3 months of randomization.
Measured: up to 3 months from randomization
Secondary outcomes (9)
Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy.
Number of participants with abnormal stool-based test who complete a diagnostic colonoscopy within 90 days of intervention.
Measured: up to 90 days from intervention
Number of participants who complete screening.
Number of participants who complete screening (stool-based testing or colonoscopy) within 90 days of randomization.
Measured: up to 90 days from randomization
Number of participants who achieve the primary endpoint.
Number of participants who achieve the primary endpoint (screening or scheduling of screening) at 6 months post randomization.
Measured: 6 months post randomization
Number of participants who achieve the primary endpoint by message type.
Number of participants who achieve the primary endpoint (screening scheduling or completion rate at 90 days) by message type (message A/B/C).
Measured: up to 90 days from randomization
Number of participants who complete screening within 6 months of initial outreach.
Number of participants who complete screening within 6 months of initial outreach by text message type (message A/B/C).
Measured: up to 6 months from initial outreach
Number of participants who complete screening colonoscopy within 6 months of initial outreach.
Number of participants who complete screening colonoscopy within 6 months of initial outreach by text message type (message A/B/C).
Measured: up to 6 months from initial outreach
Number of participants who provide any response.
Number of participants who provide any response to text messages by message type (message A/B/C).
Measured: 7, 14, 21, and 90 days
Number of participants who achieve the primary outcome from among those who did and did not respond to any text message.
Number of participants who achieve the primary outcome from among those who did and did not respond to any text message.
Measured: 6 months post randomization
Number of providers who respond to reminders.
Number of providers who respond to provider reminders through MyChart message, phone call, or in-clinic discussion.
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start23 Jun 2026
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Yale 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include adults who receive care at a local, multisite federally qualified health center, who have outstanding orders for colorectal cancer screening.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilana Richman, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345676
- Sponsor's protocol ID
- 2000041322
- Status last verified
- Jul 2026
- First submitted
- 7 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Evidence-Based Interventions to Improve Colorectal Cancer Screening Adherence in Community Health Clinics
- ClinicalTrials.gov ID
- NCT07345676
- Acronym / sponsor ID
- 2000041322
- Conditions
- Colo-rectal Cancer
- Keywords
- Screening adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Jan 2026 (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 is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study will include adults who receive care at a local, multisite federally qualified health center, who have outstanding orders for colorectal cancer screening.
| Arm | Type | Receives |
|---|---|---|
| Control-Usual Care | No intervention | –Participants will receive a simple text message reminder |
| Messaging Group A | Experimental | Behavioral: Bundled messaging interventionParticipants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C). |
| Messaging Group B | Experimental | Behavioral: Bundled messaging interventionParticipants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C). |
| Messaging Group C | Experimental | Behavioral: Bundled messaging interventionParticipants will receive a series of outreach messages including texts with two-way messaging capabilities, mailed letter, and a reminder to their clinician. Content of the text message arm will be varied so that patients receive one of three messages (A, B or C). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established adult medicine patient at Cornell Scott Hill health (defined as having a CSHH primary care doctor or >1 adult medicine visits in the last year).
- Incomplete colorectal cancer screening test defined as an outstanding order for colonoscopy or stool-based CRC screening (e.g., fecal immunochemical test (FIT) or FIT-DNA testing), but no evidence of test completion at the time of randomization. Orders must have been placed between 90-365 days prior to randomization.
- OR
- Abnormal stool-based test without follow-up, defined as an abnormal stool-based test result (e.g., positive FIT or FIT-DNA) with no completed diagnostic colonoscopy within 90 days of the result. Patients who meet this criterion will be included in a non randomized arm of the study.
Key exclusion criteria (1 listed)
- Because this is a pragmatic study of a behavioral intervention to improve colorectal cancer screening adherence, any participants who otherwise meet the inclusion criteria will not be excluded.
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 |
|---|---|---|
| Bundled messaging interventionA bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary. | Behavioural | Messaging Group A, Messaging Group B, Messaging Group C |
Primary outcome
Number of participants with scheduled or completed colorectal cancer screening.
Time frame: up to 3 months from randomization
Number of participants who completed or scheduled screening (colonoscopy or stool-based test) within 3 months of randomization.
9 secondary outcomes
Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy.
Time frame: up to 90 days from intervention
Number of participants who complete screening.
Time frame: up to 90 days from randomization
Number of participants who achieve the primary endpoint.
Time frame: 6 months post randomization
Number of participants who achieve the primary endpoint by message type.
Time frame: up to 90 days from randomization
Number of participants who complete screening within 6 months of initial outreach.
Time frame: up to 6 months from initial outreach
Number of participants who complete screening colonoscopy within 6 months of initial outreach.
Time frame: up to 6 months from initial outreach
Number of participants who provide any response.
Time frame: 7, 14, 21, and 90 days
Number of participants who achieve the primary outcome from among those who did and did not respond to any text message.
Time frame: 6 months post randomization
Number of providers who respond to reminders.
Time frame: 6 months post randomization
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Ilana Richman, MD principal investigator
Yale 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 Bundled messaging intervention in people with Colo-rectal Cancer, run by Yale 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 1 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 7 Jul 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 Ilana Richman, MD (203 737 1024, ilana.richman@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with scheduled or completed colorectal cancer screening. (time frame: up to 3 months from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.