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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Smart Symptom Tracking ALEX) | Experimental | Participants engage with the Smart Symptom Tracking ALEX app daily and receive reminders weekly for 4 weeks. |
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| Arm 2 (paper logs) | Active Comparator | Participants complete paper logs daily and receive reminders weekly for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence-based Intervention | Other | Engage with the Smart Symptom Tracking ALEX app |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom-tracking frequency | Will be defined as the number of entries logged (ALEX application or pencil-paper logs). | Over 4 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enhancing Technology & Communication in Healthcare (ETCH) Lab | Contact | 904-953-5375 | ETCH@mayo.edu | |
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Janice Krieger, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Best Practice | Other | Complete paper logs |
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| Communication Intervention | Other | Receive reminders |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 4 weeks |
| 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. | At baseline and at week 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. | Up to 4 weeks |
| Engagement metrics (ALEX arm) | Will measure application analytics (days with entries, interaction with coaching modules, and notifications opened). Will be reported using descriptive summaries (median daily engagement). | Up to 4 weeks |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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