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临床试验/NCT03235999
NCT03235999已完成不适用

The Experiences of Patients Living With Malignant Pleural Effusions

Gloucestershire Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Patient Experiences of living with malignant pleural effusion and different pleural procedures

研究概览

简要总结

Up to 20 patients with malignant pleural effusions will be interviewed about their experiences of having this condition and its management.

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

  • Adults diagnosed with a malignant pleural effusion
  • Has undergone either talc pleurodesis or IPC
  • Have signed a consent form prior to entering the study
  • Life expectancy > 6 weeks based on LENT guidelines (Low/Moderate risk group) - The LENT score calculation assigns 0 (<1500 IU/L) or 1 (>1500 IU/L) for pleural fluid LDH level; 0 to 3 points for matching ECOG performance scores (3 and 4 are combined); 0 (<9) or 1 (>9) for neutrophil-to-lymphocyte ratio; and 0 (lowest risk), 1 (moderate risk), or 3 (highest risk) for tumor type.

排除标准

  • Any patient who is unable to understand sufficient English to take part in the semi-structured interviews
  • Weakness or fatigue sufficient so that the patient is unable to take part in the interviews

结局指标

主要结局

Patient Experiences of living with malignant pleural effusion and different pleural procedures

时间窗: 4 weeks after IPC placement or talc pleurodesis

Qualitative interviews - Interviews will be recorded on a digital audio recorder and then downloaded on to a password protected computer. The interviews will then be sent for transcription using secure email and anonymised. We will perform thematic analysis on the interview data. This is a process to help explore the experiences of the subject as they describe it rather than looking at how they talk about the experience. Themes will be drawn from the data following coding. Common codes relating to a theme, for example pain, will be identified and examples of text used to demonstrate the theme extracted. This will ensure a wide variety of quotes across the interviews rather than focusing on one main or a subset of interviews. We will use an inductive approach whereby themes will emerge and not be developed in advance. Emerging codes will be checked by the supervisory team. There will be no numerical, quantitative data for analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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