NCT07107152

Brief Summary

The goal of this clinical trial is to assess whether messages generated by a large language model (LLM), including both static and conversational formats, can increase colorectal cancer (CRC) screening intentions among U.S. adults aged 45-75 who have never completed CRC screening. The main questions it aims to answer are: Do personalized, AI-generated messages increase the self-reported likelihood of completing a stool-based CRC screening test within 12 months? Do they also increase intent to undergo colonoscopy screening within 12 months? Researchers will compare four groups: (1) no message control, (2) expert-written patient education materials, (3) a single AI-generated persuasive message, and (4) a motivational interviewing-style AI chatbot. These comparisons will help assess whether a conversational format offers added benefit over static AI or expert-generated content. Participants will: Be randomly assigned to one of the four study arms Spend at least 3 minutes reading or interacting with their assigned material Complete pre- and post-intervention surveys assessing intent to receive CRC screening Receive messages tailored to their self-reported demographics, including age, political ideology, gender, education, community setting (urban, rural, suburb), self-reported health, and the last time they saw their PCP

Trial Health

87
On Track

Trial Health Score

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

Enrollment
915

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 11, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

10 days

First QC Date

July 30, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

chatbotArtificial Intelligencelarge language modelscolorectal cancer screening

Outcome Measures

Primary Outcomes (2)

  • Change in Self-Reported Likelihood of Completing Stool Test Screening for Colorectal Cancer

    Measured on a 0-100 scale, where 0 = "Extremely unlikely" and 100 = "Extremely likely." Assessed before and after the intervention. Change in score indicates difference in participant intention to complete a stool-based CRC screening test.

    Immediately before and after the intervention (single session; same day)

  • Change in Self-Reported Likelihood of Completing Colonoscopy Screening for Colorectal Cancer

    Measured on a 0-100 scale, where 0 = "Extremely unlikely" and 100 = "Extremely likely." Assessed before and after the intervention. Change in score reflects shift in participant intention to complete a colonoscopy within the next 12 months.

    Immediately before and after the intervention (single session; same day)

Secondary Outcomes (4)

  • Perceived Empathy of the Intervention

    Immediately after the intervention (single session)

  • Comfort Discussing CRC Screening with a Provider

    Immediately before and after the intervention (single session; same day)

  • Perceived Message Effectiveness

    Immediately after the intervention (single session)

  • Change in Reasons for CRC Screening Hesitancy

    Immediately before and after the intervention (single session)

Study Arms (4)

AI Motivational Interviewing Chatbot

EXPERIMENTAL

The motivational interviewing chatbot refers to a GPT-4.1 based chatbot that has been instructed to follow motivational interviewing principals to persuade participants to get screened for CRC.

Behavioral: AI Chatbot

single GPT generated message

EXPERIMENTAL

The single GPT generated message is a single \~640 word persuasive message generated by GPT-4.1 where GPT-4.1 is provided with the same self-reported demographics.

Behavioral: single GPT generated message

CRC JAMA patient page

ACTIVE COMPARATOR

The 642 word JAMA Patient Page contains up to date information on screening guidelines for CRC directed at patients.

Behavioral: Expert-Written Patient Materials

No Message

NO INTERVENTION

Participants read a \~640 word fictional short story about a cat and dog.

Interventions

Participants receive a single \~640-word message generated by GPT-4.1. The message is tailored to participants' self-reported demographics (age, gender, political ideology, education, urbanicity, health status, and last PCP visit). The message provides persuasive content encouraging colorectal cancer screening, emphasizing stool and colonoscopy screening options. Participants are required to read the message for a minimum of 3 minutes.

single GPT generated message
AI ChatbotBEHAVIORAL

Participants engage in a multi-turn conversation with a GPT-4.1 chatbot trained to emulate motivational interviewing techniques. The chatbot personalizes its conversation based on each participant's demographics (age, gender, political ideology, education, urbanicity, health status, and last PCP visit). Conversations last at least 3 minutes and aim to increase participant motivation to complete colorectal cancer screening.

AI Motivational Interviewing Chatbot

Participants read a 642-word expert-written educational summary from the Journal of the American Medical Association's Patient Page on colorectal cancer screening. The material is designed to provide objective information about screening options and guidelines recommended by the US Preventive Services Task Force. Participants are required to read the material for at least 3 minutes.

CRC JAMA patient page

Eligibility Criteria

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

You may qualify if:

  • Adults aged 45 to 75 years
  • Currently residing in the United States
  • Self-reported no prior colorectal cancer screening (or unsure if screened)
  • Able to read and understand English
  • Consent to participate in a behavioral research study

You may not qualify if:

  • Previous colonoscopy, stool test, sigmoidoscopy, or CT colonography
  • Failure to pass pre- or post-intervention attention checks
  • Identified as non-human respondents by reCAPTCHA or other automated bot detection
  • Completion time significantly shorter than the median, indicating inattentiveness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Participants are recruited online via Prolific

Philadelphia, Pennsylvania, 19104, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

June 11, 2025

Primary Completion

June 21, 2025

Study Completion

June 21, 2025

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Locations