Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization (CoSMMO)

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, we will learn from clinic staff and patients what their needs and preferences are in terms of use of technology. We will use this information to design the text messages program.

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

Second, we 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, we 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, we 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools; Behavioral: Screening Concerns Text Message; Behavioral: Personalized Text Message; Behavioral: Live Support Outreach; Behavioral: Impediments Support Outreach; Behavioral: Autonomy Support Outreach

Detailed Description

We will conduct a study to optimize text messages and approaches to outreach by community health centers to increase their 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.

Our study design includes three parts. First, we will optimize the text messages to maximize patient engagement and outreach (Aims 1 & 2). We will enroll patients from three partnering CHCs to participate in six focus groups to inform message design. We 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, we will conduct a factorial experiment, randomizing 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, we will optimize outreach strategies for CRC screening completion. In a second factorial experiment with 5,100 patients we 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, we 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, we will assess implementation outcomes and sustainment of intervention components and effects. We 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.

• Study Type: Interventional
• Enrollment (Estimated): 7220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yamila Sierra; Phone Number: 303-724-4811; Email: yamila.sierra@cuanschutz.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Stephanie Martinez, MPH; Phone Number: 617-643-4995; Email: smartinez7@mgb.org
      • Sub-Investigator: Adjoa Anyane-Yeboa, MD, MPH
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
      • Contact: Soumya Mohanty, MBBS, MD, MPH; Phone Number: 857-263-9746; Email: soumya_mohanty@dfci.harvard.edu
      • Sub-Investigator: Kasisomayajula Viswanath, PhD
    • Boston, Massachusetts, United States, 02108
      • The Massachusetts League of Community Health Center, Inc.
      • Contact: Susan Dargon-Hart, LICSW; Phone Number: 617-877-6535; Email: sdargonhart@massleague.org
      • Principal Investigator: Susan Dargon-Hart
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
      • Contact: Lynn N Ibekwe-Agunanna, PhD, MPH; Phone Number: 214-645-2532; Email: Lynn.Ibekwe-Agunanna@utsouthwestern.edu
      • Sub-Investigator: Lynn Ibekwe-Agunanna, MPH, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Message - Gain Frame; No personalization, no concerns/negative emotion, gain-framed message.	Behavioral: Message Framing Text Message; Use gain-framed language to influence motivation.; Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Experimental: Concern Message - Gain Frame; No personalization, screening concerns/negative emotions, gain-framed message.	Behavioral: Message Framing Text Message; Use gain-framed language to influence motivation.; Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Screening Concerns Text Message; Emotional concerns or barriers related to CRC screening.
Experimental: Concern Message - No Gain Frame; No personalization, screening concerns/negative emotions, no gain-framed message.	Behavioral: Message Framing Text Message; Use gain-framed language to influence motivation.; Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Screening Concerns Text Message; Emotional concerns or barriers related to CRC screening.
Experimental: Standard Message - No Gain Frame; No personalization, no screening concerns/negative emotions, no gain-framed message.	Behavioral: Message Framing Text Message; Use gain-framed language to influence motivation.; Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Experimental: Personalized Message - Gain Frame; Personalization included, no screening concerns/negative emotions, gain-framed message.	Behavioral: Message Framing Text Message; Use gain-framed language to influence motivation.; Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Personalized Text Message; Message includes personalized content.
Experimental: Personalized Message - No Gain Frame; Personalization included, no screening concerns/negative emotions, no gain-framed message.	Behavioral: Message Framing Text Message; Use gain-framed language to influence motivation.; Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Personalized Text Message; Message includes personalized content.
Experimental: Personalized - Concern Message - Gain Frame; Personalization and screening concerns/negative emotions, gain framed message.	Behavioral: Message Framing Text Message; Use gain-framed language to influence motivation.; Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Screening Concerns Text Message; Emotional concerns or barriers related to CRC screening.
Experimental: Personalized - Concern Message - No Gain Frame; Personalization and screening concerns/negative emotions, no gain-framed message.	Behavioral: Message Framing Text Message; Use gain-framed language to influence motivation.; Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Screening Concerns Text Message; Emotional concerns or barriers related to CRC screening.
Experimental: Basic Outreach Only; No autonomy support, no impediments support, no live support.	Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Live Support Outreach; Offer access to live assistance.
Experimental: Outreach + Impediments Support; No autonomy support, no live support. Impediment support.	Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Impediments Support Outreach; Include information or resources to help overcome barriers to care.
Experimental: Outreach + Impediments + Live Support; No autonomy support. Impediment support and live support included.	Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Live Support Outreach; Offer access to live assistance.; Behavioral: Impediments Support Outreach; Include information or resources to help overcome barriers to care.
Experimental: Outreach + Live Support; Live support included. No autonomy or impediments support.	Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Live Support Outreach; Offer access to live assistance.
Experimental: Autonomy Outreach Support; Autonomy support included, no impediments or live support.	Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Autonomy Support Outreach; Provide patients with choices or options to increase sense of control.
Experimental: Autonomy + Live Support; Autonomy and live support with impediments support.	Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Live Support Outreach; Offer access to live assistance.; Behavioral: Autonomy Support Outreach; Provide patients with choices or options to increase sense of control.
Experimental: Autonomy + Impediments Support; Autonomy and impediments support included. No live support included.	Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Impediments Support Outreach; Include information or resources to help overcome barriers to care.; Behavioral: Autonomy Support Outreach; Provide patients with choices or options to increase sense of control.
Experimental: Autonomy + Impediments + Live Support; Autonomy, impediments, and live support included.	Other: Data Reporting and Visualization System Tools; Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.; Behavioral: Live Support Outreach; Offer access to live assistance.; Behavioral: Impediments Support Outreach; Include information or resources to help overcome barriers to care.; Behavioral: Autonomy Support Outreach; Provide patients with choices or options to increase sense of control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Text message engagement	Interaction with CRC screening reminder messages by reply	14 days after reminder message delivery
Stool-based CRC screening completion	Stool-based CRC screening test resulted in electronic health record	3 months after reminder message delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to follow-up care after abnormal stool-based screening test	Time (days) to follow-up care after abnormal stool-based screening test	3 months after date of abnormal result
Invalid test results	Invalid stool-based screening test result	3 months after reminder message delivery

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI); Massachusetts General Hospital; Dana-Farber Cancer Institute; National Institutes of Health (NIH); University of Texas Southwestern Medical Center; Massachusetts League of Community Health Centers
• Investigators: Principal Investigator: Gina Kruse, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: colorectal cancer screening; Text messaging; Community Health Centers (CHC)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Investigative Techniques; Methods; Research Design
• Other Study ID Numbers: 25-1144.cc; R01CA293501 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be available when the project is complete. The data will be maintained for 7 years on our servers, per our standard practice.
• IPD Sharing Access Criteria: The primary restriction will be approval of data use requests by the participating community health centers' leadership. We will share the data with potential users who have a legitimate and appropriate use for data of this nature. Because the data is owned by the participating health centers, data use requests will be reviewed and approved by the health centers' leadership committee. Since the data is owned by the participating community health centers, a data use agreement will be created to allow for use and analysis by the collaborating researchers. All data use requests will be made to Dr. Kruse, who will discuss them with the study team and with CHC leadership, before any data use agreements are made and data is released.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No