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

Mayo Clinic

Status: Enrolling

Conditions: Colorectal Carcinoma

Treatments: Other: Communication Intervention; Other: Questionnaire Administration; Other: Best Practice; Other: Artificial Intelligence-based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07618273

26-000152

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm 1 (Smart Symptom Tracking ALEX)

Experimental group

Description:

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

Treatment:

Other: Artificial Intelligence-based Intervention

Other: Questionnaire Administration

Other: Communication Intervention

Arm 2 (paper logs)

Active Comparator group

Description:

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

Treatment:

Other: Best Practice

Other: Questionnaire Administration

Other: Communication Intervention