Evaluation of Short and Long External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patients' self-rated quality of life - change from baseline compared to 2 and 4 weeks post catheter insertion.
研究概览
简要总结
This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction.
详细描述
Pleural effusion is a medical condition, which occurs when too much fluid collects in the space between the lungs and the chest wall. This extra fluid makes it hard for the lungs to fully expand and take in enough air when inhaling. Malignant pleural effusions (MPE) are effusions related to cancer. Common symptoms of MPE include: dyspnea (shortness of breath), cough, weight loss, and chest pain. Tunneled pleural catheters (which are inserted into the body) are now commonly used to treat the symptoms of malignant pleural effusions by draining this extra fluid on a daily basis. This drainage can be done and home and need not be performed at a hospital.
The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction. The Rocket® pleural catheter has been approved by the Food and Drug Administration (FDA) and Health Canada for the management of malignant pleural effusions.
This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. All information required to evaluate the Rocket® catheter will be collected from routine medical follow-up visits. The period of time for the study is approximately 4 weeks (28 days).
The Rocket® catheter will be provided to patients who wish to participate in this study. If patients do not wish to participate, they will receive the current standard of care (the PleurX catheter) and will undergo the same standard medical assessments that will be performed in this study.
All patients eligible for the study will have a regular full length Rocket catheter inserted at baseline, with an external length of 16cm. All patients will have their catheter length modified at 2 weeks in clinic and shortened to an external length of 5cm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Presence of symptomatic (BDI < 6), and moderate sized (> 1/3 of hemithorax) MPE
- •Persistent malignant pleural effusion that is free flowing
- •Life expectancy of at least 2 months (approximate duration of follow-up for the study)
- •Age greater than 18
- •Consent to undergoing TPC treatment for recurrent MPE
排除标准
- •Prior attempted chemical pleurodesis on ipsilateral side
- •Active pleural or pulmonary infection
- •Currently hospitalized for reasons other than MPE or in hospice care
- •Life expectancy estimated at less than 2 months
- •Inability to complete questionnaires (English or French)
- •Refusal to give informed consent
- •Pregnant women
结局指标
主要结局
Patients' self-rated quality of life - change from baseline compared to 2 and 4 weeks post catheter insertion.
时间窗: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28.
Self-rated QOL at baseline compared to 2 weeks and 4 weeks post catheter insertion. Quality of life will be assessed using the validated EORTC QLQ-C30 (European Organization of Research and Treatment of Cancer Quality of Life Evaluation) questionnaire.
Patients' self-rated quality of life on domains specific to lung cancer-change from baseline compared to 2 and 4 weeks post catheter insertion.
时间窗: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28.
Self-rated QOL in domains specific to lung cancer will be assessed at baseline compared to 2 weeks and 4 weeks post catheter insertion. Quality of life will be assessed using the validated lung cancer specific EORTC QLQ-LC13 (European Organization of Research and Treatment of Cancer (EORTC) Quality of Life QLQ-LC13 disease specific) questionnaire.
次要结局
- Ease of use of the short versus long Rocket® pleural catheter.(Questionnaire will be administered at routine medical visits on day O, 14, and 28.)
- Feasibility: measured by incidence of complications (adverse events reports)(Complications will be quantified and described based on patients' reporting of adverse events (at 2 week and 4 week medical assessments). Satisfaction with device questionnaires will be administered at routine medical visits on day 0, 14 and 28.)