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NCT Number: NCT07569250

Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization

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.

* 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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria for CHC Patients Cohorts

Inclusion criteria

(CHC Patients):

  • 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)

Exclusion criteria

(CHC Patients):

  • 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

Exclusion criteria

(CHC Staff)

  • None

Treatment and study plan

Personalized Text Message

Behavioral

Message includes personalized content.

Screening Concerns Text Message

Behavioral

Emotional concerns or barriers related to CRC screening.

Message Framing Text Message

Behavioral

Use gain-framed language to influence motivation.

Autonomy Support Outreach

Behavioral

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

Impediments Support Outreach

Behavioral

Include information or resources to help overcome barriers to care.

Live Support Outreach

Behavioral

Offer access to live assistance.

Data Reporting and Visualization System Tools

Other

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

Primary outcomes

  1. Text message engagement

    Time frame: 14 days after reminder message delivery

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

  2. Stool-based CRC screening completion

    Time frame: 3 months after reminder message delivery

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

Secondary outcomes

  1. Time to follow-up care after abnormal stool-based screening test

    Time frame: 3 months after date of abnormal result

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

  2. Invalid test results

    Time frame: 3 months after reminder message delivery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yamila Sierra

CONTACT

[email protected]

303-724-4811

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Massachusetts League of Community Health Centers
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • University of Texas Southwestern Medical Center

Registry information

Acronym: CoSMMO

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
May 6, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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