| Registry | NCT07569250, acronym CoSMMO |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, factorial, masking: none, health services research |
| Enrollment | 7220 (Estimated) |
| Sponsor | University of Colorado, Denver (Other); collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI), Massachusetts League of Community Health Centers, Dana-Farber Cancer Institute, University of Texas Southwestern Medical Center, Massachusetts General Hospital |
| Conditions | Colorectal Cancer |
| Interventions | Personalized Text Message, Screening Concerns Text Message, Message Framing Text Message, Autonomy Support Outreach, Impediments Support Outreach, Live Support Outreach, Data Reporting and Visualization System Tools (Behavioral, other) |
| Dates | start 2026-12-01 (estimated), primary completion 2031-10-01 (estimated), completion 2032-01-01 (estimated), first posted 2026-05-06, last updated 2026-07-10 |
| Locations | 4 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Colorectal Cancer All trials of Personalized Text Message All trials of Screening Concerns Text Message
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standard Message - Gain Frame | Experimental | Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools | No personalization, no concerns/negative emotion, gain-framed message. |
| Concern Message - Gain Frame | Experimental | Behavioral: Screening Concerns Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools | No personalization, screening concerns/negative emotions, gain-framed message. |
| Concern Message - No Gain Frame | Experimental | Behavioral: Screening Concerns Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools | No personalization, screening concerns/negative emotions, no gain-framed message. |
| Standard Message - No Gain Frame | Experimental | Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools | No personalization, no screening concerns/negative emotions, no gain-framed message. |
| Personalized Message - Gain Frame | Experimental | Behavioral: Personalized Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools | Personalization included, no screening concerns/negative emotions, gain-framed message. |
| Personalized Message - No Gain Frame | Experimental | Behavioral: Personalized Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools | Personalization included, no screening concerns/negative emotions, no gain-framed message. |
| Personalized - Concern Message - Gain Frame | Experimental | Behavioral: Screening Concerns Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools | Personalization and screening concerns/negative emotions, gain framed message. |
| Personalized - Concern Message - No Gain Frame | Experimental | Behavioral: Screening Concerns Text Message; Behavioral: Message Framing Text Message; Other: Data Reporting and Visualization System Tools | Personalization and screening concerns/negative emotions, no gain-framed message. |
| Basic Outreach Only | Experimental | Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools | No autonomy support, no impediments support, no live support. |
| Outreach + Impediments Support | Experimental | Behavioral: Impediments Support Outreach; Other: Data Reporting and Visualization System Tools | No autonomy support, no live support. Impediment support. |
| Outreach + Impediments + Live Support | Experimental | Behavioral: Impediments Support Outreach; Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools | No autonomy support. Impediment support and live support included. |
| Outreach + Live Support | Experimental | Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools | Live support included. No autonomy or impediments support. |
| Autonomy Outreach Support | Experimental | Behavioral: Autonomy Support Outreach; Other: Data Reporting and Visualization System Tools | Autonomy support included, no impediments or live support. |
| Autonomy + Live Support | Experimental | Behavioral: Autonomy Support Outreach; Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools | Autonomy and live support with impediments support. |
| Autonomy + Impediments Support | Experimental | Behavioral: Autonomy Support Outreach; Behavioral: Impediments Support Outreach; Other: Data Reporting and Visualization System Tools | Autonomy and impediments support included. No live support included. |
| Autonomy + Impediments + Live Support | Experimental | Behavioral: Autonomy Support Outreach; Behavioral: Impediments Support Outreach; Behavioral: Live Support Outreach; Other: Data Reporting and Visualization System Tools | Autonomy, impediments, and live support included. |
Sex: All, ages: 45 Years to 75 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| The Massachusetts League of Community Health Center, Inc. | Boston, Massachusetts | United States | |
| Massachusetts General Hospital | Boston, Massachusetts | United States | |
| Dana Farber Cancer Institute | Boston, Massachusetts | United States | |
| University of Texas Southwestern Medical Center | Dallas, Texas | United States |
NIH grants: R01CA293501