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

2 giugno 2026 aggiornato da: University of Colorado, Denver

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

7220

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital
        • Contatto:
        • Sub-investigatore:
          • Adjoa Anyane-Yeboa, MD, MPH
      • Boston, Massachusetts, Stati Uniti, 02215
        • Dana Farber Cancer Institute
        • Contatto:
        • Sub-investigatore:
          • Kasisomayajula Viswanath, PhD
      • Boston, Massachusetts, Stati Uniti, 02108
        • The Massachusetts League of Community Health Center, Inc.
        • Contatto:
        • Investigatore principale:
          • Susan Dargon-Hart
    • Texas
      • Dallas, Texas, Stati Uniti, 75390
        • University of Texas Southwestern Medical Center
        • Contatto:
        • Sub-investigatore:
          • Lynn Ibekwe-Agunanna, MPH, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Standard Message - Gain Frame
No personalization, no concerns/negative emotion, gain-framed message.
Comportamentale: Message Framing Text Message
Use gain-framed language to influence motivation.
Altro: 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.
Sperimentale: Concern Message - Gain Frame
No personalization, screening concerns/negative emotions, gain-framed message.
Comportamentale: Message Framing Text Message
Use gain-framed language to influence motivation.
Altro: 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.
Comportamentale: Screening Concerns Text Message
Emotional concerns or barriers related to CRC screening.
Sperimentale: Concern Message - No Gain Frame
No personalization, screening concerns/negative emotions, no gain-framed message.
Comportamentale: Message Framing Text Message
Use gain-framed language to influence motivation.
Altro: 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.
Comportamentale: Screening Concerns Text Message
Emotional concerns or barriers related to CRC screening.
Sperimentale: Standard Message - No Gain Frame
No personalization, no screening concerns/negative emotions, no gain-framed message.
Comportamentale: Message Framing Text Message
Use gain-framed language to influence motivation.
Altro: 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.
Sperimentale: Personalized Message - Gain Frame
Personalization included, no screening concerns/negative emotions, gain-framed message.
Comportamentale: Message Framing Text Message
Use gain-framed language to influence motivation.
Altro: 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.
Comportamentale: Personalized Text Message
Message includes personalized content.
Sperimentale: Personalized Message - No Gain Frame
Personalization included, no screening concerns/negative emotions, no gain-framed message.
Comportamentale: Message Framing Text Message
Use gain-framed language to influence motivation.
Altro: 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.
Comportamentale: Personalized Text Message
Message includes personalized content.
Sperimentale: Personalized - Concern Message - Gain Frame
Personalization and screening concerns/negative emotions, gain framed message.
Comportamentale: Message Framing Text Message
Use gain-framed language to influence motivation.
Altro: 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.
Comportamentale: Screening Concerns Text Message
Emotional concerns or barriers related to CRC screening.
Sperimentale: Personalized - Concern Message - No Gain Frame
Personalization and screening concerns/negative emotions, no gain-framed message.
Comportamentale: Message Framing Text Message
Use gain-framed language to influence motivation.
Altro: 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.
Comportamentale: Screening Concerns Text Message
Emotional concerns or barriers related to CRC screening.
Sperimentale: Basic Outreach Only
No autonomy support, no impediments support, no live support.
Altro: 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.
Comportamentale: Live Support Outreach
Offer access to live assistance.
Sperimentale: Outreach + Impediments Support
No autonomy support, no live support. Impediment support.
Altro: 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.
Comportamentale: Impediments Support Outreach
Include information or resources to help overcome barriers to care.
Sperimentale: Outreach + Impediments + Live Support
No autonomy support. Impediment support and live support included.
Altro: 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.
Comportamentale: Live Support Outreach
Offer access to live assistance.
Comportamentale: Impediments Support Outreach
Include information or resources to help overcome barriers to care.
Sperimentale: Outreach + Live Support
Live support included. No autonomy or impediments support.
Altro: 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.
Comportamentale: Live Support Outreach
Offer access to live assistance.
Sperimentale: Autonomy Outreach Support
Autonomy support included, no impediments or live support.
Altro: 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.
Comportamentale: Autonomy Support Outreach
Provide patients with choices or options to increase sense of control.
Sperimentale: Autonomy + Live Support
Autonomy and live support with impediments support.
Altro: 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.
Comportamentale: Live Support Outreach
Offer access to live assistance.
Comportamentale: Autonomy Support Outreach
Provide patients with choices or options to increase sense of control.
Sperimentale: Autonomy + Impediments Support
Autonomy and impediments support included. No live support included.
Altro: 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.
Comportamentale: Impediments Support Outreach
Include information or resources to help overcome barriers to care.
Comportamentale: Autonomy Support Outreach
Provide patients with choices or options to increase sense of control.
Sperimentale: Autonomy + Impediments + Live Support
Autonomy, impediments, and live support included.
Altro: 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.
Comportamentale: Live Support Outreach
Offer access to live assistance.
Comportamentale: Impediments Support Outreach
Include information or resources to help overcome barriers to care.
Comportamentale: Autonomy Support Outreach
Provide patients with choices or options to increase sense of control.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Text message engagement
Lasso di tempo: 14 days after reminder message delivery
Proportion of message recipients who interact with CRC screening reminder messages by reply
14 days after reminder message delivery
Stool-based CRC screening completion
Lasso di tempo: 3 months after reminder message delivery
Proportion of message recipients with stool-based CRC screening tests resulted in electronic health record
3 months after reminder message delivery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to follow-up care after abnormal stool-based screening test
Lasso di tempo: 3 months after date of abnormal result
Time (days) to follow-up care after abnormal stool-based screening test
3 months after date of abnormal result
Invalid test results
Lasso di tempo: 3 months after reminder message delivery
Proportion of message recipients with invalid stool-based screening test result
3 months after reminder message delivery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Colorado, Denver

Collaboratori

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

Investigatori

  • Investigatore principale: Gina Kruse, MD, University of Colorado, Denver

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 ottobre 2031

Completamento dello studio (Stimato)

1 gennaio 2032

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-1144.cc
  • R01CA293501 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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