NCT Number: NCT07618273
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.
Interested in participating?
Request Info18 year–44 year
All sexes
Interventional
Not applicable
Jacksonville, Florida, 32224-9980, United States
Location status: Recruiting
Clinical Trials Referral Office
CONTACT
Enhancing Technology & Communication in Healthcare (ETCH) Lab
CONTACT
Janice L. Krieger, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Engage with the Smart Symptom Tracking ALEX app
Other names: AI Intervention, AI-based Intervention
Complete paper logs
Other names: standard of care, standard therapy
Receive reminders
Ancillary studies
Time frame: At baseline and at 4 weeks
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: Over 4 weeks
Will be defined as the number of entries logged (ALEX application or pencil-paper logs).
Time frame: Up to 4 weeks
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: At baseline and at week 4
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: Up to 4 weeks
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
Will measure application analytics (days with entries, interaction with coaching modules, and notifications opened). Will be reported using descriptive summaries (median daily engagement).
Contact information is provided by the study sponsor or research team.
Clinical Trials Referral Office
CONTACT
Enhancing Technology & Communication in Healthcare (ETCH) Lab
CONTACT
Mayo Clinic
Other
Smart Horizons Pilot: A Feasibility and Outcomes Evaluation of Digital Symptom Tracking for Gastrointestinal Health
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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