Health-related Quality of Life Outcomes and Changes in Sarcopenia in Patients With Refractory Ascites
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life scores as measured by the PROMIS-10 questionnaire
研究概览
简要总结
Clinical data regarding quality of life in patients with refractory ascites is limited and preceded the development of newer questionnaires that may be more robust. One primary objective of this study is to study changes in quality in life in a prospective fashion using newer general and ascites-specific quality of life survey instruments specific to benign and malignant etiologies.
Sarcopenia is a condition that is prevalent in cancer and cirrhosis. Current data is retrospective and associative, evaluating heterogeneous patient populations at different stages within the timeline of refractory ascites. The other primary objective of this study is to study sarcopenia in a prospective fashion and to understand its kinetics once a patient develops refractory ascites.
Prospectively-obtained measures of deterioration in patient-reported outcomes and in muscle mass will form the basis for the next stage of investigation of interventions to mitigate these declines.
详细描述
Patients with refractory ascites defined as requiring >1 paracentesis within a 6 week period will be prospectively enrolled. The Patient-Reported Outcomes Measurement Information System (PROMIS-10) and ascites-specific (Ascites Q and Edmonton Symptom Assessment System: Ascites Modification) quality of life questionnaires will be obtained at baseline, then at 1-, 2-, 4- and 6 months. Sarcopenia will be assessed by muscle area measurement from a single CT image at the L4 level at baseline, 2- and 6 months.
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
- •Eastern Cooperative Oncology Group (ECOG) performance score < 3
- •Refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment.
- •Capable of giving informed consent
排除标准
- •Life expectancy less than 3 months
- •Unable to participate in neuropsychological tests/questionnaires
- •Pregnant or nursing women. .
结局指标
主要结局
Health-Related Quality of Life scores as measured by the PROMIS-10 questionnaire
时间窗: 6 months
Patient-Reported Outcomes Measurement Information System (PROMIS-10) survey scores physical and mental health on a 4-20 point scale which are combined into an overall score with higher scores reflecting better quality of life.
Sarcopenia as measured by psoas, paraspinal, and total abdominal wall muscle areas
时间窗: 6 months
assessed by a limited CT scan of the abdomen at the level of L4. Cross-sectional muscle area is measured.
次要结局
- Ascites-specific QOL scores as measured by the Ascites Q for patients with cirrhotic ascites.(6 months)
- Ascites-specific QOL scores as measured by the Edmonton Symptom Assessment System: Ascites Modification for patients with malignant ascites,(6 months)
研究者
Michael C Soulen, MD
Director Interventional Oncology
Abramson Cancer Center at Penn Medicine