Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Determine if there is change in the QoL
研究概览
简要总结
The purpose of this study is look at how treatments for ascites affect quality of life. Your quality of life is the ability for you to enjoy the normal things you do. Ascites (pronounced as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is caused by cancer, also called malignancy.
All people who participate in this study have ascites associated with cancer. Ascites can cause symptoms that make it difficult for the patient to do simple things. Patients with ascites often report:
Abdominal swelling Difficulty walking. Difficulty breathing. Feeling full when eating. Clothes not fitting due to a swollen abdomen. Swelling in the legs. It is hoped that this catheter will relieve the symptoms of the ascites. The goal of the investigators study is to understand the quality of life before the procedure and after the procedure. Since the patient is having this procedure to make their symptoms better, the investigators want to hear from the patient of how the procedure has affected their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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 diagnosed with a stage IV malignancy or end-stage disease documented in patient's chart.
- •Patients referred to interventional radiology for treatment of refractory ascites with the placement of a permanent catheter including, but not limited to, a Tenckhoff catheter, a PleurX catheter, or a Denver Shunt.
- •Fluency in English to enable instrument and interview completion.
- •Patients must be at least 18 years of age.
- •Patients must be physically capable of completing instruments and/or interview.
- •Patients must be able to comprehend and execute informed consent.
排除标准
- •Unable to complete questionnaire due to a significant physical or mental deficits as assessed by the consenting professional.
- •Proxy completion is not accepted
- •Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument
结局指标
主要结局
Determine if there is change in the QoL
时间窗: 2 years
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
Determine if there is change in symptoms
时间窗: 2 years
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
次要结局
- Determine the impact ascites has on quality of life(2 years)
- Monitor and describe post-catheter placement morbidity and mortality.(2 years)