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| Name | Class |
|---|---|
| Florida Cancer Innovation Fund | UNKNOWN |
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This observational study aims to (1) validate a multimodal artificial intelligence (AI) model for early detection of cancer-associated cachexia in pancreatic cancer patients and (2) assess the feasibility and acceptability of diet and exercise interventions for cachexia management. The study will use retrospective data from the Florida Pancreas Collaborative and prospective data from newly diagnosed patients at Moffitt Cancer Center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic Cancer Patients | Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma. |
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| Oncology Clinicians | Medical oncologists, APPs, dietitians involved in pancreatic cancer care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline Lifestyle and Symptom Assessment | Other | Dietary questionnaire (VioScreen), symptom and QoL surveys (ESAS-r, FAACT, PROMIS PF, PG-SGA), physical activity survey (Modified GLTEQ), functional fitness tests, DEXA scans, blood draws. |
| Measure | Description | Time Frame |
|---|---|---|
| AI Model Performance | Investigators will rigorously assess model performance using clinically meaningful metrics (AUC-ROC, sensitivity, specificity, etc.) to confirm its reliability and readiness for clinical use. | Up to 9 months |
| Survey Completion Rate | Percentage of patients completing all scheduled questionnaires. | Up to 9 months |
| Wearable Adherence | Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks. | Up to 9 months |
| Quality of Life Change | Mean change in FAACT total score from baseline to 9 months. | Up to 9 months |
| Physical Activity Change | Mean increase in weekly moderate-to-vigorous activity minutes. | Up to 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (≥18 years) with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC), presenting with resectable, borderline resectable, or locally advanced nonmetastatic disease. ECOG performance status 0-2. Total enrollment includes 100 newly diagnosed pancreatic cancer patients (cross-sectional), a longitudinal subset of 50 patients followed for 9 months, and 20 oncology clinicians completing feasibility surveys.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjukta Bhattacharjee | Contact | 813-745-0279 | Sanjukta.Bhattacharjee@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Ghulam Rasool, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Extended Lifestyle Monitoring | Other | Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months. |
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| Feasibility Survey | Other | One-time structured survey assessing integration of diet and exercise interventions into clinical workflow. |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |