Personalized Text Message
BehavioralMessage includes personalized content.
NCT Number: NCT07569250
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.
Trial opening soon.
Get Notified45 year–75 year
All sexes
Interventional
Not applicable
Dana Farber Cancer Institute, Boston, Massachusetts, United States
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.
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):
Exclusion criteria
(CHC Patients):
Eligibility Criteria for CHC Staff Cohorts Inclusion Criteria (CHC Staff)
Exclusion criteria
(CHC Staff)
Message includes personalized content.
Emotional concerns or barriers related to CRC screening.
Use gain-framed language to influence motivation.
Provide patients with choices or options to increase sense of control.
Include information or resources to help overcome barriers to care.
Offer access to live assistance.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Time frame: 14 days after reminder message delivery
Proportion of message recipients who interact with CRC screening reminder messages by reply
Time frame: 3 months after reminder message delivery
Proportion of message recipients with stool-based CRC screening tests resulted in electronic health record
Time frame: 3 months after date of abnormal result
Time (days) to follow-up care after abnormal stool-based screening test
Time frame: 3 months after reminder message delivery
Proportion of message recipients with invalid stool-based screening test result
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Acronym: CoSMMO
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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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