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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-44
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ages 18-44 years

Concerned about their GI health

Able to speak and read English

Willing to complete a four-week symptom tracking protocol

Disqualifiers

Unable to understand the informed consent or comply with protocol requirements

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artificial Intelligence-based Intervention

    Other intervention

    Engage with the Smart Symptom Tracking ALEX app

  • Best Practice

    Other intervention

    Complete paper logs

  • Communication Intervention

    Other intervention

    Receive reminders

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm 1 (Smart Symptom Tracking ALEX)Experimental treatment 3 interventions
Group B: Arm 2 (paper logs)Active comparator 3 interventions

Trial outcomes

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.

Time frame
At baseline and at 4 weeks

Secondary outcomes

1

Symptom-tracking frequency

Will be defined as the number of entries logged (ALEX application or pencil-paper logs).

Time frame
Over 4 weeks
2

Symptom-report detail and quality

Will be assessed by qualitative review of report detail (e.g., presence of descriptors, specificity, and red-flag indicators). Will be reported using descriptive summaries of coding categories.

Time frame
Up to 4 weeks
3

Communication readiness and symptom-disclosure confidence

Will be measured by 4 self-report questions answered on a Likert-type scale where 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=somewhat confident, and 5=extremely confident. Higher scores indicate greater confident in readiness to communication symptoms with confidence.

Time frame
At baseline and at week 4
4

Intervention acceptability and usability (ALEX arm only)

Will be measured using the 2-question System Usability Scale (answered on a scale of 1-5 where 1=strongly disagree and 5=strongly agree) or other study-specific acceptability measures. Will be reported using descriptive statistics of acceptability and usability scores.

Time frame
Up to 4 weeks

Other outcomes

Sponsors and contacts

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