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Colorectal CancerCoSMMONCT07569250

Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization

A study testing Personalized Text Message, Screening Concerns Text Message and Message Framing Text Message in people with Colorectal Cancer, run by University of Colorado, Denver at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this interventional study is to create and test a comprehensive and low burden text message program within existing Community Health Centers (CHC) electronic records system to encourage patients to complete at home colorectal cancer (CRC) screening and to make sure they get follow-up care if their results… Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
Personalized Text Message, Screening Concerns Text Message and Message Framing Text Message
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,220 participants
Where
4 sitesUnited States
Study dates
Dec 2026to Jan 2032
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults 45-75 years old
  • Receive care in partner CHCs
  • Are of average risk for colorectal cancer
  • Received a stool-based testing order at their CHC
  • Have a mobile phone and can receive text messages (Aim 1 quantitative cohort only)
  • Fluent in English, Spanish, or another predominant language to be identified by the PI (applicable to patients focus groups cohort only)

Who cannot join

  • Personal or family history of CRC or colorectal polyps
  • History of inflammatory bowel disease
  • Heritable conditions that put them at above average risk for colorectal cancer (e.g., familial adenomatous polyposis)
  • Eligibility Criteria for CHC Staff Cohorts Inclusion Criteria (CHC Staff)
  • Adult employees of participating CHCs
  • Job responsibilities include activities related to CRC screening
  • None

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States4 sites
  • The Massachusetts League of Community Health Center, Inc.

    Boston, Massachusetts, 02108

    Susan Dargon-Hart, LICSW, 617-877-6535, sdargonhart@massleague.org

    Susan Dargon-Hart

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Stephanie Martinez, MPH, 617-643-4995, smartinez7@mgb.org

    Adjoa Anyane-Yeboa, MD, MPH

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Soumya Mohanty, MBBS, MD, MPH, 857-263-9746, soumya_mohanty@dfci.harvard.edu

    Kasisomayajula Viswanath, PhD

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Lynn N Ibekwe-Agunanna, PhD, MPH, 214-645-2532, Lynn.Ibekwe-Agunanna@utsouthwestern.edu

    Lynn Ibekwe-Agunanna, MPH, PhD

Other trials in United States

About this study

The goal of this interventional study is to create and test a comprehensive and low burden text message program within existing Community Health Centers (CHC) electronic records system to encourage patients to complete at home colorectal cancer (CRC) screening and to make sure they get follow-up care if their results are abnormal.

First, the investigators will learn from clinic staff and patients what their needs and preferences are in terms of use of technology. This information will be used to design the text messages program.

Read more
  • Clinic patients will participate in focus groups
  • Clinic staff will participate in interviews

Second, the investigators will test a series of different message versions in two batches (experiments):

  • Clinic patients with orders for an at-home colorectal cancer screening kit will receive the different message versions.
  • In the first batch, the messages that get the most engagement from patients will be selected to be used in the second experiment.
  • In the second batch, the investigators will test which messages lead to the most colorectal cancer screening completion.
  • This will be rolled-out within the clinics existing electronic record system. The study team will not receive any information that will identify individual patients.

Lastly, the investigators will check again with clinic staff to learn how the program performed, and what would be needed to continue using the text message program in the long run.

-Clinic staff will participate in interviews and surveys.

Read the detailed description

This trial is studying optimization of text messages and outreach approaches by community health centers to increase patients' completion of FIT colon cancer screening tests. Text message reminders are a low cost, scalable way to deliver patient reminders that are low burden for staff. The proposed work uses a creative, community-engaged, systems-level approach to improve completion of FIT testing and abnormal follow-up and program sustainment in CHCs.

The study design includes three parts. First, the text messages will be optimized to maximize patient engagement and outreach (Aims 1 \& 2). The study will enroll patients from three partnering CHCs to participate in six focus groups to inform message design. The investigators will also conduct key informant interviews with 5-15 staff per CHC regarding the logistics of ensuring seamless integration into routine clinical operations and perspectives on the intervention activities. Then, a factorial experiment will be conducted, assigning 2,000 patients who have received a stool-based screening kit to different reminder messages. Engagement will be measured as replies or use of ≥1 links, to indicate interaction with the message. The experiment will compare: (1) personalization; (2) concern or negative emotions about screening; and (3) gain framing. In the factorial design patients will not be individually enrolled, this intervention will be tested within the workflows of usual practice. All data for the factorial experiment will be de-identified.

With those tools in place, the investigators will optimize outreach strategies for CRC screening completion. In a second factorial experiment with 5,100 patients, the investigators will optimize outreach strategy for primary screening outcomes of home-based stool screening test completion and screening completion by any guideline-recommended CRC screening test. Secondary outcomes include follow-up care for abnormal stool test results. In this factorial experiment, the investigators will test the impact of three outreach conditions on screening completion: increasing patient autonomy, providing information for accessing resources for impediments to care, and provision of live support. As in the first factorial test, for the second factorial test patients will not be individually enrolled, as the intervention will be tested within the workflows of usual practice. All data will be de-identified.

Finally, the study will assess implementation outcomes and sustainment of intervention components and effects. The investigators will conduct staff interviews and surveys to assess organizational capacity for sustaining the intervention elements being tested as well as the acceptability and feasibility of the text messages and screening tools. Sustainment of the text message outreach intervention elements will be assessed at post intervention and two 6-month intervals post-intervention.

Being tested
Personalized Text Message, Screening Concerns Text Message, Message Framing Text Message, Autonomy Support Outreach, Impediments Support Outreach
Keywords
colorectal cancer screening, Text messaging, Community Health Centers (CHC)
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Text MessageBehavioural

    Message includes personalized content.

  • Screening Concerns Text MessageBehavioural

    Emotional concerns or barriers related to CRC screening.

  • Message Framing Text MessageBehavioural

    Use gain-framed language to influence motivation.

  • Autonomy Support OutreachBehavioural

    Provide patients with choices or options to increase sense of control.

  • Impediments Support OutreachBehavioural

    Include information or resources to help overcome barriers to care.

  • Live Support OutreachBehavioural

    Offer access to live assistance.

  • Data Reporting and Visualization System ToolsOther

    Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.

Study groups in NCT07569250
Study groupRoleWhat they receive
Standard Message - Gain FrameExperimentalNo personalization, no concerns/negative emotion, gain-framed message.
Receives: Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools
Concern Message - Gain FrameExperimentalNo personalization, screening concerns/negative emotions, gain-framed message.
Receives: Behavioral: Screening Concerns Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools
Concern Message - No Gain FrameExperimentalNo personalization, screening concerns/negative emotions, no gain-framed message.
Receives: Behavioral: Screening Concerns Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools
Standard Message - No Gain FrameExperimentalNo personalization, no screening concerns/negative emotions, no gain-framed message.
Receives: Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools
Personalized Message - Gain FrameExperimentalPersonalization included, no screening concerns/negative emotions, gain-framed message.
Receives: Behavioral: Personalized Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools
Personalized Message - No Gain FrameExperimentalPersonalization included, no screening concerns/negative emotions, no gain-framed message.
Receives: Behavioral: Personalized Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools
Personalized - Concern Message - Gain FrameExperimentalPersonalization and screening concerns/negative emotions, gain framed message.
Receives: Behavioral: Screening Concerns Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools
Personalized - Concern Message - No Gain FrameExperimentalPersonalization and screening concerns/negative emotions, no gain-framed message.
Receives: Behavioral: Screening Concerns Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools
Basic Outreach OnlyExperimentalNo autonomy support, no impediments support, no live support.
Receives: Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools
Outreach + Impediments SupportExperimentalNo autonomy support, no live support. Impediment support.
Receives: Behavioral: Impediments Support Outreach; Other: Data Reporting and Visualization System Tools
Outreach + Impediments + Live SupportExperimentalNo autonomy support. Impediment support and live support included.
Receives: Behavioral: Impediments Support Outreach; Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools
Outreach + Live SupportExperimentalLive support included. No autonomy or impediments support.
Receives: Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools
Autonomy Outreach SupportExperimentalAutonomy support included, no impediments or live support.
Receives: Behavioral: Autonomy Support Outreach; Other: Data Reporting and Visualization System Tools
Autonomy + Live SupportExperimentalAutonomy and live support with impediments support.
Receives: Behavioral: Autonomy Support Outreach; Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools
Autonomy + Impediments SupportExperimentalAutonomy and impediments support included. No live support included.
Receives: Behavioral: Autonomy Support Outreach; Behavioral: Impediments Support Outreach; Other: Data Reporting and Visualization System Tools
Autonomy + Impediments + Live SupportExperimentalAutonomy, impediments, and live support included.
Receives: Behavioral: Autonomy Support Outreach; Behavioral: Impediments Support Outreach; Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Text message engagement

    Proportion of message recipients who interact with CRC screening reminder messages by reply

    Measured: 14 days after reminder message delivery

  2. Stool-based CRC screening completion

    Proportion of message recipients with stool-based CRC screening tests resulted in electronic health record

    Measured: 3 months after reminder message delivery

Secondary outcomes (2)
  1. Time to follow-up care after abnormal stool-based screening test

    Time (days) to follow-up care after abnormal stool-based screening test

    Measured: 3 months after date of abnormal result

  2. Invalid test results

    Proportion of message recipients with invalid stool-based screening test result

    Measured: 3 months after reminder message delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionOct 2031 (estimated)
  4. Study completionJan 2032 (estimated)

Resources

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
Factorial
Masking
None (open label)
Enrolment
7,220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07569250
Sponsor's protocol ID
25-1144.cc
Other IDs
R01CA293501
Acronym
CoSMMO
Status last verified
Jul 2026
First submitted
29 Apr 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All EHR derived data or data on text message intervention interactions, and any descriptive quality improvement data that we receive from the CHCs are de-identified. If qualitative data is shared, transcripts would be stripped of all identifiers.

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Text Message, Screening Concerns Text Message and Message Framing Text Message in people with Colorectal Cancer, run by University of Colorado, Denver at 4 sites 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 10 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 4 sites 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 Yamila Sierra (303-724-4811, yamila.sierra@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Text message engagement (time frame: 14 days after reminder message delivery). The study lists 2 primary outcomes in all. 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 10 Jul 2026.

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