Patient Reported Outcomes Measures in Patients Undergoing Pancreatic Resections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change from Baseline in Quality of Life Measured by EORTC QLQ-C30 Scale up to 24 Months Post-Operatively
研究概览
简要总结
The standard of care for a patient with resectable pancreatic is to perform pancreatic resection which, even in the modern era is associated with significant complications and impact on quality of life, often in the setting of poor survival even in the best scenario. Currently, there is a lack of data on patient quality of life after such procedures, how quality of life changes throughout the course of care, and whether patients who undergo these procedures are satisfied with their decision. This research is aimed to understand the impact of pancreatic surgery on patients' quality of life, how that impact changes over time, and patient satisfaction (or regret) with their decisions. This work will help improve the pre-operative conversation to help patients decide whether undergoing a pancreatic resection aligns with their post-operative goals of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients >18 years old who undergo pancreatic resection for any indication of any race, gender, or ethnicity who are fluent in English
排除标准
- •<18 years old
- •Deemed not to have capacity to consent.
结局指标
主要结局
Change from Baseline in Quality of Life Measured by EORTC QLQ-C30 Scale up to 24 Months Post-Operatively
时间窗: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
The EORTC QLQ-C30 is a validated 30-item questionnaire assessing cancer-specific quality of life. The Global Health Status/QoL scale ranges from 0 to 100, with higher scores representing better quality of life. Unit of Measure: points Metric: Mean change from baseline Aggregation Method: Mean (SD) across participants
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic Cancer Module (EORTC QLQ-PAN26) Subscale Scores up to 24 Months Post-Operatively
时间窗: Baseline, Immediately Post-op, 3, 6, 12, 18, and 24 months after surgery
The EORTC QLQ-PAN26 is a 26-item, disease-specific questionnaire designed for patients with pancreatic cancer. It is used alongside the core EORTC QLQ-C30. PAN26 assesses multiple domains, including pancreatic pain, digestive symptoms, altered bowel habits, hepatic symptoms, and emotional effects. Each subscale is linearly transformed to a score from 0 to 100. For symptom subscales, higher scores = worse symptoms. For functioning domains, higher scores = greater impairment. Unit of Measure: points (0-100) per subscale Metric: mean change from baseline Aggregation: mean (SD) across participants
次要结局
- Change from Baseline in Social Functioning (PROMIS) up to 24 Months Post-Operatively(Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery)
- Change from Baseline in Emotional Functioning (PROMIS) up to 24 Months Post-Operatively(Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery)
- Change from Baseline in Shared Decision-Making up to 24 Months Post-Operatively(Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery)
- Change from Baseline in Grit Scale (Duckworth 12-item) Total Score up to 12 Months Post-Operatively(Baseline, 6, and 12 months after surgery)
- Change from Baseline in Brief Resilience Scale (BRS) Score up to 24 Months Post-Operatively(Baseline, Immediately Post-Op, 3, 6, 12, and 24 months after surgery)
- Change from Baseline in COST-FACIT (Comprehensive Score for Financial Toxicity) Score up to 24 Months Post-Operatively(Baseline, Immediately Post-op, 3, 6, 12, 18, and 24 months after surgery)
- Change in Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) Total Score up to 24 Months Post-Operatively(Immediately Post-op, 3, 6, 12, 18, and 24 months after surgery)
- Change in Patient Decision Regret Scale (Brehaut et al., 2003) Total Score up to 24 Months Post-Operatively(Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery)
- Change in Surgeon Decision Regret Scale (Brehaut et al., 2003) Total Score up to 12 Months Post-Operatively(Immediately Post-Op, 3, and 12 months after surgery)
- Change from Baseline in Neuropathy Symptom Scores Using NCI PRO-CTCAE® Custom Item Subset up to 24 Months Post-Operatively(Baseline, 3, 6, 12, 18, and 24 months after surgery)