Recruiting

Smart Symptom Tracking

Sponsor:

Mayo Clinic

Code:

NCT07618273

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

Artificial Intelligence-based Intervention

Best Practice

Communication Intervention

Questionnaire Administration

Study Details

Brief 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. 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

Study ID

NCT07618273

Start date

Apr 20, 2026

Status verified date

Jun, 2026

Completion date

Apr 20, 2029

Anticipated

Primary completion date

Apr 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ages 18-44 years
  • Concerned about their GI health
  • Able to speak and read English
  • Willing to complete a four-week symptom tracking protocol

Exclusion Criteria:

  • Unable to understand the informed consent or comply with protocol requirements

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Arm 1 (Smart Symptom Tracking ALEX)

Participants engage with the Smart Symptom Tracking ALEX app daily and receive reminders weekly for 4 weeks.

active comparator: Arm 2 (paper logs)

Participants complete paper logs daily and receive reminders weekly for 4 weeks.

Interventions

Artificial Intelligence-based Intervention

Engage with the Smart Symptom Tracking ALEX app

Best Practice

Complete paper logs

Communication Intervention

Receive reminders

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Change in gastrointestinal self-advocacy [ Time Frame: At baseline and at 4 weeks ]

Central Contacts and Locations

Central contacts

Enhancing Technology & Communication in Healthcare (ETCH) Lab

904-953-5375ETCH@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Enhancing Technology & Communication in Healthcare (ETCH) Lab

904-953-5375ETCH@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Janice L. Krieger, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-05.