Smart Symptom Tracking ALEX Application for Tracking and Monitoring Gastrointestinal Health, Smart Horizons Pilot Trial

NCT07618273 | Recruiting

• 1 other identifier: 26-000152
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and at 4 weeks

Secondary Outcomes (5)

• Symptom-tracking frequency

  Over 4 weeks

• Symptom-report detail and quality

  Up to 4 weeks

• Communication readiness and symptom-disclosure confidence

  At baseline and at week 4

• Intervention acceptability and usability (ALEX arm only)

  Up to 4 weeks

• Engagement metrics (ALEX arm)

  Up to 4 weeks

Study Arms (2)

Arm 1 (Smart Symptom Tracking ALEX)

EXPERIMENTAL

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

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.

Other: Best Practice; Other: Communication Intervention; Other: Questionnaire Administration

Interventions

Artificial Intelligence-based Intervention OTHER

Engage with the Smart Symptom Tracking ALEX app

Also known as: AI Intervention, AI-based Intervention

Arm 1 (Smart Symptom Tracking ALEX)

Best Practice OTHER

Complete paper logs

Also known as: standard of care, standard therapy

Arm 2 (paper logs)

Communication Intervention OTHER

Receive reminders

Arm 1 (Smart Symptom Tracking ALEX); Arm 2 (paper logs)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (Smart Symptom Tracking ALEX); Arm 2 (paper logs)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Janice Krieger, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enhancing Technology & Communication in Healthcare (ETCH) Lab

CONTACT

904-953-5375; ETCH@mayo.edu

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

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: May 19, 2026
• First Posted: June 1, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

US (1)