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临床试验/NCT03550690
NCT03550690Unknown不适用

The Quality of Life of Patients Who Have Rocket Indwelling Pleural Catheter Drainage or Repeated Large Volume Paracentesis - Observational Feasibility Study

Gloucestershire Hospitals NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2018年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Percentage presence and percentage completeness of the three QOL measures

研究概览

简要总结

Ascites (accumulation of fluid in the abdominal cavity) is a common problem which can lead to distressing symptoms. When caused by cancer, management options are chemotherapy, diuretics and ascitic drainage. Ascitic drainage is performed by inserting a plastic tube into the abdomen and draining off the fluid under local anaesthetic, removing the drain afterwards. For some, the fluid will return and the procedure needs repeating. A relatively new treatment involves inserting a semi-permanent drain - a small plastic tube under the skin which is left in place so that the fluid can be drained if it builds up again. The potential benefit to patients is that afterwards they can have fluid removed at home. This might reduce the number of hospital admissions, outpatient visits and the number of procedures they need to have in the last few months of life. In Gloucestershire, the Rocket Indwelling Pleural Catheter (IPC) is the semi-permanent drain of choice.

Our research group has a particular interest in the management of ascites and we recently completed the first qualitative interview study with patients with this condition - patients with ascites secondary to cancer. Patients were pleased to have semi-permanent drains in place as it meant that repeated admissions to hospital were avoided. They did not have to wait for a build-up of fluid before more could be drained off; and symptoms never had to build up as badly as when they were having repeated ascitic drainage.

We plan a feasibility study to ascertain whether a definitive non-randomised study to detect differences in quality of life between Rocket IPC and repeat ascitic drainage is possible and how many patients would be needed for such a study.

详细描述

Study Objective This feasibility study aims to establish how best to conduct a definitive prospective non-randomised QOL study for patients with malignant ascites who either have placement of a Rocket IPC or repeated LVP

Study Design This is an open label, non-randomised observational study. Each patient will receive verbal and written information followed by signing of an Informed Consent Form prior to participation. They will be asked to capture data about their QOL by completing paper diaries.

If the patient has a relative / next of kin we will ask permission from the patient to approach them to see if they would be happy to consent to helping with data collection for the study.

Study Procedures

When patients are booked for ascitic drainage in hospitals or hospice a member of the patient's clinical team will discuss the study with the patient (either in person or via telephone). If in agreement, the doctor / nurse will pass on their contact details to a member of the research team who will then telephone the patient and:

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

入选标准

  • Male or female adult patients
  • Have ascites due to cancer undergoing treatment at Gloucestershire Hospitals NHS Foundation Trust
  • Planned to have an ascitic tap within a week
  • Thought to have an estimated prognosis of 12 weeks or more
  • Willing and able to provide signed written informed consent
  • Patient Exclusion Criteria
  • Patients who, in the opinion of the clinical team, would be too distressed by the idea of participation.
  • Patients who might not adequately understand verbal explanations or written information given in English.
  • Relative Inclusion Criteria:
  • Adult supporting patient participant in Rocket Project 1
  • Happy to support patient with completion of patient diaries
  • Relative Exclusion Criteria
  • Relatives who, in the opinion of the clinical team, would be too distressed by the idea of participation.
  • Relatives who might not adequately understand verbal explanations or written information given in English.

排除标准

  • 未提供

结局指标

主要结局

Percentage presence and percentage completeness of the three QOL measures

时间窗: 3 months

次要结局

  • Complications(3 months)
  • Anti-cancer treatment received by the patient(3 months)
  • Diuretics received by the patient(3 months)
  • The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM) DAILY(3 months)
  • The EuroQol questionnaire (EQ-5D) as a generic QOL measure DAILY(3 months)
  • The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL Questionnaire (QLQ-C30) WEEKLY(3 months)
  • Volumes of fluid removed at LVPs OR number of Rocket IPC bottles used at Rocket IPC drainage(3 months)
  • Number of LVPs / Rocket IPC drainage episodes performed(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Perkins

Consultant in Palliative Medicine

Gloucestershire Hospitals NHS Foundation Trust

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