Colorectal CarcinomaNCT07618273
Smart Symptom Tracking ALEX Application for Tracking and Monitoring Gastrointestinal Health, Smart Horizons Pilot Trial
A study testing Artificial Intelligence-based Intervention, Best Practice and Communication Intervention in people with Colorectal Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial compares the impact of the Smart Symptom Tracking ALEX application (app) to standard symptom-tracking practices in tracking and monitoring gastrointestinal (GI) symptoms in young adults. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Artificial Intelligence-based Intervention, Best Practice and Communication Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to 20 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-44 years
- Concerned about their GI health
- Able to speak and read English
- Willing to complete a four-week symptom tracking protocol
Who cannot join
- Unable to understand the informed consent or comply with protocol requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Enhancing Technology & Communication in Healthcare (ETCH) Lab, 904-953-5375, ETCH@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this study
Official title: Smart Horizons Pilot: A Feasibility and Outcomes Evaluation of Digital Symptom Tracking for Gastrointestinal Health
This clinical trial compares the impact of the Smart Symptom Tracking ALEX application (app) to standard symptom-tracking practices in tracking and monitoring gastrointestinal (GI) symptoms in young adults. Rates of early-onset colorectal cancer are rising sharply and it is projected to become the leading cause of cancer-related death in young adults. Despite this, adults under 45 still face barriers to diagnosis, including access to screening, unclear guidance on the impact of GI symptoms and dismissal of symptoms by healthcare providers. Current screening guidelines lack guidance on monitoring early symptoms in younger adults. The Smart Symptom Tracking ALEX tool is a digital platform that uses artificial intelligence to provide prompts for symptoms, coaching, reminders and education. Standard of care clinical practices include paper-based logs to report symptoms. Using the Smart Symptom Tracking ALEX app may provide more detailed symptom reports and increase self-reported symptom communication compared to standard symptom-tracking practices in young adults concerned about their GI health.
- Conditions
- Colorectal Carcinoma
- Being tested
- Artificial Intelligence-based Intervention, Best Practice, Communication Intervention, Questionnaire Administration
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-based InterventionOther
Also called AI Intervention, AI-based Intervention
Engage with the Smart Symptom Tracking ALEX app
Best PracticeOther
Also called standard of care, standard therapy
Complete paper logs
Communication InterventionOther
Receive reminders
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Smart Symptom Tracking ALEX) | Experimental | Participants engage with the Smart Symptom Tracking ALEX app daily and receive reminders weekly for 4 weeks. Receives: Other: Artificial Intelligence-based Intervention; Other: Communication Intervention; Other: Questionnaire Administration |
| Arm 2 (paper logs) | Active comparator | Participants complete paper logs daily and receive reminders weekly for 4 weeks. Receives: Other: Best Practice; Other: Communication Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal self-advocacy
Will use a 4-items self-report "How confident are you in..." scale and chart-verified data to assess baseline and post-intervention self-advocacy. Questions are answered on a 5-point scale where 1=not at all confident and 5=extremely confident. Higher scores indicate greater self-advocacy confidence. Will compare mean change between arms using analysis of covariance (ANCOVA) or linear regression adjusting for baseline scores. Will estimate effect sizes (Cohen's d) and 95% confidence intervals. Sensitivity analysis will use mixed-effects models for repeated measures.
Measured: At baseline and at 4 weeks
Secondary outcomes (5)
Symptom-tracking frequency
Will be defined as the number of entries logged (ALEX application or pencil-paper logs).
Measured: Over 4 weeks
Symptom-report detail and quality
Will be assessed by qualitative review of report detail (e.g., presence of descriptors, specificity, and red-flag indicators). Will be reported using descriptive summaries of coding categories.
Measured: Up to 4 weeks
Communication readiness and symptom-disclosure confidence
Will be measured by 4 self-report questions answered on a Likert-type scale where 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=somewhat confident, and 5=extremely confident. Higher scores indicate greater confident in readiness to communication symptoms with confidence.
Measured: At baseline and at week 4
Intervention acceptability and usability (ALEX arm only)
Will be measured using the 2-question System Usability Scale (answered on a scale of 1-5 where 1=strongly disagree and 5=strongly agree) or other study-specific acceptability measures. Will be reported using descriptive statistics of acceptability and usability scores.
Measured: Up to 4 weeks
Engagement metrics (ALEX arm)
Will measure application analytics (days with entries, interaction with coaching modules, and notifications opened). Will be reported using descriptive summaries (median daily engagement).
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start20 Apr 2026
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice Krieger, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618273
- Sponsor's protocol ID
- 26-000152
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Horizons Pilot: A Feasibility and Outcomes Evaluation of Digital Symptom Tracking for Gastrointestinal Health
- ClinicalTrials.gov ID
- NCT07618273
- Acronym / sponsor ID
- 26-000152
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2029 (estimated)
- First posted
- 1 Jun 2026 (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.
This clinical trial compares the impact of the Smart Symptom Tracking ALEX application (app) to standard symptom-tracking practices in tracking and monitoring gastrointestinal (GI) symptoms in young adults. Rates of early-onset colorectal cancer are rising sharply and it is projected to become the leading cause of cancer-related death in young adults. Despite this, adults under 45 still face barriers to diagnosis, including access to screening, unclear guidance on the impact of GI symptoms and dismissal of symptoms by healthcare providers. Current screening guidelines lack guidance on monitoring early symptoms in younger adults. The Smart Symptom Tracking ALEX tool is a digital platform that uses artificial intelligence to provide prompts for symptoms, coaching, reminders and education. Standard of care clinical practices include paper-based logs to report symptoms. Using the Smart Symptom Tracking ALEX app may provide more detailed symptom reports and increase self-reported symptom communication compared to standard symptom-tracking practices in young adults concerned about their GI health.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Smart Symptom Tracking ALEX) | Experimental | Other: Artificial Intelligence-based Intervention, Other: Communication Intervention, Other: Questionnaire AdministrationParticipants engage with the Smart Symptom Tracking ALEX app daily and receive reminders weekly for 4 weeks. |
| Arm 2 (paper logs) | Active comparator | Other: Best Practice, Other: Communication Intervention, Other: Questionnaire AdministrationParticipants complete paper logs daily and receive reminders weekly for 4 weeks. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-44 years
- Concerned about their GI health
- Able to speak and read English
- Willing to complete a four-week symptom tracking protocol
Key exclusion criteria (1 listed)
- Unable to understand the informed consent or comply with protocol requirements
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 |
|---|---|---|
| Artificial Intelligence-based InterventionAlso: AI Intervention, AI-based InterventionEngage with the Smart Symptom Tracking ALEX app | Other | Arm 1 (Smart Symptom Tracking ALEX) |
| Best PracticeAlso: standard of care, standard therapyComplete paper logs | Other | Arm 2 (paper logs) |
| Communication InterventionReceive reminders | Other | Arm 1 (Smart Symptom Tracking ALEX), Arm 2 (paper logs) |
| Questionnaire AdministrationAncillary studies | Other | Arm 1 (Smart Symptom Tracking ALEX), Arm 2 (paper logs) |
Primary outcome
Change in gastrointestinal self-advocacy
Time frame: At baseline and at 4 weeks
Will use a 4-items self-report "How confident are you in..." scale and chart-verified data to assess baseline and post-intervention self-advocacy. Questions are answered on a 5-point scale where 1=not at all confident and 5=extremely confident. Higher scores indicate greater self-advocacy confidence. Will compare mean change between arms using analysis of covariance (ANCOVA) or linear regression adjusting for baseline scores. Will estimate effect sizes (Cohen's d) and 95% confidence intervals. Sensitivity analysis will use mixed-effects models for repeated measures.
5 secondary outcomes
Symptom-tracking frequency
Time frame: Over 4 weeks
Symptom-report detail and quality
Time frame: Up to 4 weeks
Communication readiness and symptom-disclosure confidence
Time frame: At baseline and at week 4
Intervention acceptability and usability (ALEX arm only)
Time frame: Up to 4 weeks
Engagement metrics (ALEX arm)
Time frame: Up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Janice Krieger, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-based Intervention, Best Practice and Communication Intervention in people with Colorectal Carcinoma, run by Mayo Clinic 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enhancing Technology & Communication in Healthcare (ETCH) Lab (904-953-5375, ETCH@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastrointestinal self-advocacy (time frame: At baseline and at 4 weeks). 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 5 Jun 2026.