AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- AI Model Performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histologically or cytologically confirmed diagnosis of pancreatic exocrine malignancy (e.g.pancreatic ductal adenocarcinoma, acinar cell carcinoma, pancreatic adenosquamous carcinoma, etc.) or clinical features highly suggestive of such malignancy with diagnostic confirmation anticipated during the screening or early study period.
- •Presentation consistent with resectable, borderline resectable, local, or locally advanced, or metastatic disease
- •May or may not have had surgery
- •Treatment plan likely includes systemic therapy for pancreatic cancer
- •ECOG performance status 0-2
- •Able to tolerate oral intake and not currently receiving enteral or parenteral nutrition
- •Able to read and speak English
- •Able to provide written informed consent
排除标准
- •Pregnant or breastfeeding at the time of enrollment
- •Current use of tube feeding (enteral) or total parenteral nutrition
- •Presence of ascites or other findings suggestive of decompensated disease
- •Evidence or history of bowel obstruction or any gastrointestinal condition that may limit food intake
- •Severe or uncontrolled psychiatric illness (e.g., psychosis, dementia) that would interfere with participation
- •Presence of other uncontrolled intercurrent illnesses (e.g., infection, heart failure, liver failure) that may interfere with protocol adherence
研究组 & 干预措施
Pancreatic Cancer Patients
Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma.
干预措施: Baseline Lifestyle and Symptom Assessment (Other)
Pancreatic Cancer Patients
Patients with newly diagnosed borderline resectable or locally advanced pancreatic adenocarcinoma.
干预措施: Extended Lifestyle Monitoring (Other)
Oncology Clinicians
Medical oncologists, APPs, dietitians involved in pancreatic cancer care.
干预措施: Feasibility Survey (Other)
结局指标
主要结局
AI Model Performance
时间窗: Up to 9 months
Investigators will rigorously assess model performance using clinically meaningful metrics (AUC-ROC, sensitivity, specificity, etc.) to confirm its reliability and readiness for clinical use.
Survey Completion Rate
时间窗: Up to 9 months
Percentage of patients completing all scheduled questionnaires.
Wearable Adherence
时间窗: Up to 9 months
Percentage of longitudinal participants syncing Fitbit weekly for ≥80% of study weeks.
Quality of Life Change
时间窗: Up to 9 months
Mean change in FAACT total score from baseline to 9 months.
Physical Activity Change
时间窗: Up to 9 months
Mean increase in weekly moderate-to-vigorous activity minutes.
次要结局
未报告次要终点