NCT07569250

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,220

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
62mo left

Started Dec 2026

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2031

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4.8 years

First QC Date

April 29, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

colorectal cancer screeningText messagingCommunity Health Centers (CHC)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

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

    3 months after date of abnormal result

  • Invalid test results

    3 months after reminder message delivery

Study Arms (16)

Standard Message - Gain Frame

EXPERIMENTAL

No personalization, no concerns/negative emotion, gain-framed message.

Behavioral: Message Framing Text MessageOther: Data Reporting and Visualization System Tools

Concern Message - Gain Frame

EXPERIMENTAL

No personalization, screening concerns/negative emotions, gain-framed message.

Behavioral: Screening Concerns Text MessageBehavioral: Message Framing Text MessageOther: Data Reporting and Visualization System Tools

Concern Message - No Gain Frame

EXPERIMENTAL

No personalization, screening concerns/negative emotions, no gain-framed message.

Behavioral: Screening Concerns Text MessageBehavioral: Message Framing Text MessageOther: Data Reporting and Visualization System Tools

Standard Message - No Gain Frame

EXPERIMENTAL

No personalization, no screening concerns/negative emotions, no gain-framed message.

Behavioral: Message Framing Text MessageOther: Data Reporting and Visualization System Tools

Personalized Message - Gain Frame

EXPERIMENTAL

Personalization included, no screening concerns/negative emotions, gain-framed message.

Behavioral: Personalized Text MessageBehavioral: Message Framing Text MessageOther: Data Reporting and Visualization System Tools

Personalized Message - No Gain Frame

EXPERIMENTAL

Personalization included, no screening concerns/negative emotions, no gain-framed message.

Behavioral: Personalized Text MessageBehavioral: Message Framing Text MessageOther: Data Reporting and Visualization System Tools

Personalized - Concern Message - Gain Frame

EXPERIMENTAL

Personalization and screening concerns/negative emotions, gain framed message.

Behavioral: Screening Concerns Text MessageBehavioral: Message Framing Text MessageOther: Data Reporting and Visualization System Tools

Personalized - Concern Message - No Gain Frame

EXPERIMENTAL

Personalization and screening concerns/negative emotions, no gain-framed message.

Behavioral: Screening Concerns Text MessageBehavioral: Message Framing Text MessageOther: Data Reporting and Visualization System Tools

Basic Outreach Only

EXPERIMENTAL

No autonomy support, no impediments support, no live support.

Behavioral: Live Support OutreachOther: Data Reporting and Visualization System Tools

Outreach + Impediments Support

EXPERIMENTAL

No autonomy support, no live support. Impediment support.

Behavioral: Impediments Support OutreachOther: Data Reporting and Visualization System Tools

Outreach + Impediments + Live Support

EXPERIMENTAL

No autonomy support. Impediment support and live support included.

Behavioral: Impediments Support OutreachBehavioral: Live Support OutreachOther: Data Reporting and Visualization System Tools

Outreach + Live Support

EXPERIMENTAL

Live support included. No autonomy or impediments support.

Behavioral: Live Support OutreachOther: Data Reporting and Visualization System Tools

Autonomy Outreach Support

EXPERIMENTAL

Autonomy support included, no impediments or live support.

Behavioral: Autonomy Support OutreachOther: Data Reporting and Visualization System Tools

Autonomy + Live Support

EXPERIMENTAL

Autonomy and live support with impediments support.

Behavioral: Autonomy Support OutreachBehavioral: Live Support OutreachOther: Data Reporting and Visualization System Tools

Autonomy + Impediments Support

EXPERIMENTAL

Autonomy and impediments support included. No live support included.

Behavioral: Autonomy Support OutreachBehavioral: Impediments Support OutreachOther: Data Reporting and Visualization System Tools

Autonomy + Impediments + Live Support

EXPERIMENTAL

Autonomy, impediments, and live support included.

Behavioral: Autonomy Support OutreachBehavioral: Impediments Support OutreachBehavioral: Live Support OutreachOther: Data Reporting and Visualization System Tools

Interventions

Message includes personalized content.

Personalized Message - Gain FramePersonalized Message - No Gain Frame

Emotional concerns or barriers related to CRC screening.

Concern Message - Gain FrameConcern Message - No Gain FramePersonalized - Concern Message - Gain FramePersonalized - Concern Message - No Gain Frame

Use gain-framed language to influence motivation.

Concern Message - Gain FrameConcern Message - No Gain FramePersonalized - Concern Message - Gain FramePersonalized - Concern Message - No Gain FramePersonalized Message - Gain FramePersonalized Message - No Gain FrameStandard Message - Gain FrameStandard Message - No Gain Frame

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

Autonomy + Impediments + Live SupportAutonomy + Impediments SupportAutonomy + Live SupportAutonomy Outreach Support

Offer access to live assistance.

Autonomy + Impediments + Live SupportAutonomy + Live SupportBasic Outreach OnlyOutreach + Impediments + Live SupportOutreach + Live Support

Include information or resources to help overcome barriers to care.

Autonomy + Impediments + Live SupportAutonomy + Impediments SupportOutreach + Impediments + Live SupportOutreach + Impediments Support

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

Autonomy + Impediments + Live SupportAutonomy + Impediments SupportAutonomy + Live SupportAutonomy Outreach SupportBasic Outreach OnlyConcern Message - Gain FrameConcern Message - No Gain FrameOutreach + Impediments + Live SupportOutreach + Impediments SupportOutreach + Live SupportPersonalized - Concern Message - Gain FramePersonalized - Concern Message - No Gain FramePersonalized Message - Gain FramePersonalized Message - No Gain FrameStandard Message - Gain FrameStandard Message - No Gain Frame

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • Adult employees of participating CHCs
  • Job responsibilities include activities related to CRC screening
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Massachusetts League of Community Health Center, Inc.

Boston, Massachusetts, 02108, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Research Design

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Gina Kruse, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 6, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

January 1, 2032

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.
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.

Locations