A Randomized, Controlled Trial Examining the Use of The "Serious Illness Conversation Guide" (SICG) in Patients With Advanced Gastro-Intestinal Cancers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference in proportions of patients with documented goals of care
研究概览
简要总结
The purpose of the study is to determine whether standardized implementation of a scripted template for discussing important issues that arise near the end of life improves the care of those who have advanced cancer.
详细描述
Primary Objective: To determine whether the Serious Illness Conversation Guide will improve the consistency with which providers have and document conversations regarding patients' goals and priorities as they near the end of life.
Secondary Objectives: 1. To assess whether having conversations as per this model will improve the quality of care near the end of life as determined by appropriate care in concordance with their goals of care.
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To assess whether having conversations as per this model will improve patient Quality of Life (QOL) as per a validated scale.
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To assess in patients with concordant care whether this model will improve patient QOL as per a validated scale 4. To assess provider opinions about end-of-life conversations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with metastatic colorectal cancer whose tumor has progressed on both FOLFOX and FOLFIRI.
- •Exception: Patients with metastatic colorectal cancer whose tumors demonstrate a BRAF V600E mutation may be enrolled regardless of prior chemotherapy.
- •Exception: Patients whose tumors are MSI-H must have experience progression through immunotherapy in addition to the therapies mentioned above.
- •Patients with metastatic pancreatic adenocarcinoma.
- •Patients with metastatic gastric or esophageal cancer whose tumor has progressed through first-line chemotherapy of any type.
- •Patients with metastatic cholangiocarcinoma whose tumor has progressed through first-line chemotherapy of any type.
- •Patients with metastatic hepatocellular carcinoma whose tumor has progressed through PD1 blockade.
- •Patients with metastatic high-grade neuroendocrine tumor.
- •A patient with a metastatic GIST that has progressed through first-line tyrosine kinase inhibitor.
- •Expected life expectancy of at least one month
排除标准
- •Any patient not meeting the above criteria
- •Non-English speaking patients
结局指标
主要结局
Difference in proportions of patients with documented goals of care
时间窗: 1 year
Difference in proportions of patients who have documented goals of care in medical records, assessed after death, for both arms
次要结局
- Difference in proportions of patients with appropriate care toward end of life(1 year)
- Overall comparison of QOL survey(1 year)
- Comparison of QOL survey measures by section(1 year)