Smart Symptom Tracking ALEX Application for Tracking and Monitoring Gastrointestinal Health, Smart Horizons Pilot Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial Intelligence-based Intervention, Best Practice, Communication Intervention, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Colorectal Carcinoma. Basic parameters: 18 years — 44 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Smart Horizons Pilot: A Feasibility and Outcomes Evaluation of Digital Symptom Tracking for Gastrointestinal Health
Overview
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.
Interventions
- Other Artificial Intelligence-based Intervention
Engage with the Smart Symptom Tracking ALEX app - Other Best Practice
Complete paper logs - Other Communication Intervention
Receive reminders - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Change in gastrointestinal self-advocacy [Time frame: At baseline and at 4 weeks]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT07618273 · 26-000152