Colorectal Cancer Control and PreventionNCT07107152
Effect of Static vs. Conversational AI-Generated Messages on Colorectal Cancer Screening Intent: a Randomized Controlled Trial
A study testing single GPT generated message, AI Chatbot and Expert-Written Patient Materials in people with Colorectal Cancer Control and Prevention, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Control and Prevention
- What is being tested?
- single GPT generated message, AI Chatbot and Expert-Written Patient Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 915 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 21 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Participants are recruited online via Prolific
Philadelphia, Pennsylvania, 19104
About this study
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?
Read more
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
- Conditions
- Colorectal Cancer Control and Prevention
- Being tested
- single GPT generated message, AI Chatbot, Expert-Written Patient Materials
- Keywords
- chatbot, Artificial Intelligence, large language models, colorectal cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single GPT generated messageBehavioural
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.
AI ChatbotBehavioural
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.
Expert-Written Patient MaterialsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Expert-Written Patient Materials |
| No Message | No intervention | Participants read a ~640 word fictional short story about a cat and dog. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately before and after the intervention (single session; same day)
Secondary outcomes (4)
Perceived Empathy of the Intervention
Participants rate how empathetic they found the assigned message or chatbot interaction using a 5-point Likert scale. Higher values indicate greater perceived empathy.
Measured: Immediately after the intervention (single session)
Comfort Discussing CRC Screening with a Provider
Measured on a 0-100 scale where 0 = "Not at all comfortable" and 100 = "Extremely comfortable." Assessed pre- and post-intervention to detect changes in self-reported comfort discussing colorectal cancer screening with a primary care provider.
Measured: Immediately before and after the intervention (single session; same day)
Perceived Message Effectiveness
Participants rate the persuasive effectiveness of the assigned content using a previously developed public health message effectiveness scale.
Measured: Immediately after the intervention (single session)
Change in Reasons for CRC Screening Hesitancy
Participants rate the importance of 13 pre-defined concerns about CRC screening on a 0-100 scale (e.g., cost, discomfort, necessity). Changes in ratings pre- to post-intervention reflect shifts in perceived barriers.
Measured: Immediately before and after the intervention (single session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start11 Jun 2025
- Primary completion21 Jun 2025
- Study completion21 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Control and PreventionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 915 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107152
- Sponsor's protocol ID
- crc_857299
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Static vs. Conversational AI-Generated Messages on Colorectal Cancer Screening Intent: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07107152
- Acronym / sponsor ID
- crc_857299
- Conditions
- Colorectal Cancer Control and Prevention
- Keywords
- chatbot, Artificial Intelligence, large language models, colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 915 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 21 Jun 2025 (actual)
- Study completion
- 21 Jun 2025 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AI Motivational Interviewing Chatbot | Experimental | Behavioral: AI ChatbotThe 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. |
| single GPT generated message | Experimental | Behavioral: single GPT generated messageThe 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. |
| CRC JAMA patient page | Active comparator | Behavioral: Expert-Written Patient MaterialsThe 642 word JAMA Patient Page contains up to date information on screening guidelines for CRC directed at patients. |
| No Message | No intervention | –Participants read a ~640 word fictional short story about a cat and dog. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single GPT generated messageParticipants 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. | Behavioural | single GPT generated message |
| AI ChatbotParticipants 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. | Behavioural | AI Motivational Interviewing Chatbot |
| Expert-Written Patient MaterialsParticipants 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. | Behavioural | CRC JAMA patient page |
Primary outcome
Change in Self-Reported Likelihood of Completing Stool Test Screening for Colorectal Cancer
Time frame: Immediately before and after the intervention (single session; same day)
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.
Change in Self-Reported Likelihood of Completing Colonoscopy Screening for Colorectal Cancer
Time frame: Immediately before and after the intervention (single session; same day)
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.
4 secondary outcomes
Perceived Empathy of the Intervention
Time frame: Immediately after the intervention (single session)
Comfort Discussing CRC Screening with a Provider
Time frame: Immediately before and after the intervention (single session; same day)
Perceived Message Effectiveness
Time frame: Immediately after the intervention (single session)
Change in Reasons for CRC Screening Hesitancy
Time frame: Immediately before and after the intervention (single session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single GPT generated message, AI Chatbot and Expert-Written Patient Materials in people with Colorectal Cancer Control and Prevention, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Reported Likelihood of Completing Stool Test Screening for Colorectal Cancer (time frame: Immediately before and after the intervention (single session; same day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.