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

Purpose

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.

Condition

  • Colorectal Carcinoma

Eligibility

Eligible Ages
Between 18 Years and 44 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 (Smart Symptom Tracking ALEX)
Participants engage with the Smart Symptom Tracking ALEX app daily and receive reminders weekly for 4 weeks.
  • Other: Artificial Intelligence-based Intervention
    Engage with the Smart Symptom Tracking ALEX app
    Other names:
    • AI Intervention
    • AI-based Intervention
  • Other: Communication Intervention
    Receive reminders
  • Other: Questionnaire Administration
    Ancillary studies
Active Comparator
Arm 2 (paper logs)
Participants complete paper logs daily and receive reminders weekly for 4 weeks.
  • Other: Best Practice
    Complete paper logs
    Other names:
    • standard of care
    • standard therapy
  • Other: Communication Intervention
    Receive reminders
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Contact:
Enhancing Technology & Communication in Healthcare (ETCH) Lab
904-953-5375
ETCH@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Enhancing Technology & Communication in Healthcare (ETCH) Lab
904-953-5375
ETCH@mayo.edu