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临床试验/NCT04125225
NCT04125225撤回不适用

An Interpretative Phenomenological Analysis of 'Recovery' Following Complete Cytoreductive Surgery.

University of Southampton1 个研究点 分布在 1 个国家开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
To gather an in-depth understanding of the experiences of patients following complete cytoreductive surgery, using interpretative phenomenological analysis

研究概览

简要总结

Complete cytoreductive surgery (CCRS) is an extensive, and potentially curative, procedure utilised for peritoneal malignancies including Pseudomyxoma peritonei (PMP). This study aims to provide a nuanced understanding of the lived experience of recovery following CCRS over time, with the view to inform future supportive measures for CCRS patients in particular. This study also provides the opportunity to longitudinally examine patient perceptions of 'recovery' in the context of major illness and/or treatment; i.e. what it is to experience recovery, what is important during recovery, perhaps how this changes over time, and what it is to be 'recovered', if this is possible. A greater understanding of the term may have implications in how it is used, or how patients following major illness are approached by healthcare professionals.

Interpretive Phenomenological Analysis (IPA) will be utilised as the guiding methodology in order to answer the study objectives. Potential participants will be approached by the clinical nurse specialist (CNS) involved in the patient's care, and will be offered a 'research study pack', containing a participant information sheet (PIS). A maximum of ten consenting participants will be interviewed on up to six occasions (although only five are planned) across a timeframe of little more than a year, both before and after their surgery. Interviews may take place face-to-face, or via telephone. Data analysis will involve a cyclical process of identifying patterns within the interview transcripts of each participant at each time point, across time points, and between participants. This design will provide an effective means of gathering and analysing rich data from each participant, thus affording a comprehensive insight into the meanings that participants attribute over time to their recovery following CCRS.

This study has been devised in partial fulfilment of a doctorate degree at the University of Southampton.

详细描述

Complete cytoreductive surgery (CCRS), an extensive procedure increasingly used to treat, and potentially cure, advanced cancers of the peritoneal cavity, including Pseudomyxoma Peritonei (PMP). In a process that can last fourteen hours a typically sizeable number of peritoneal organs or tissues (upon which cancerous cells present) are targeted for tumour nodule removal, or are resected or excised. CCRS is concluded by the administration of hyperthermic intraperitoneal chemotherapy (HIPEC), a warm chemotherapy solution which is gyrated across the peritoneal cavity for one to two hours.

Despite the magnitude of the procedure, CCRS offers the potential of prolonged survival, or indeed cure, particularly for those diagnosed with PMP. Accumulated 10-year survival rates for 1904 PMP patients after CCRS, in countries including the United Kingdom (UK), indicated survival rates of 74%.

Empirical studies conclude that 'recovery' from the procedure, to preoperative or reference population quality of life scores, across the domains of physical, emotional and psychosocial health, typically occurs 3 - 12 months postoperatively. Notably, however, the dominant paradigm of inquiry adopted in this field is positivist, with survey work accounting for 31/36 of the fully published studies located through a systematic literature search to have examined the impact of CCRS on patients. Such work is limited in its ability to explicate the personal meaning that people may attribute to their lived experience of recovery. Moreover, the remaining five studies have not acquired an understanding of personal meaning over time, across the course of postoperative recovery, in what is likely to be a profound example of postoperative experience with implications beyond those highlighted by positivistic work.

This study aims to fill this gap in the knowledge base by providing a nuanced understanding of the lived experience of recovery over time, from the perspective of patients who have undergone CCRS surgery, with the view to inform future supportive measures for CCRS patients in particular.

There is also a secondary motive for conducting this study.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are eligible to be invited to participate in the study if...
  • They are electively booked in...
  • ... for Complete Cytoreducive Surgery (CCRS)...
  • ... for 'four-quadrant' Pseudomyxoma peritonei (PMP)...
  • ... at Basingstoke and North Hampshire Hospital (BNHH).
  • They are 16 years old or over.
  • They live within an approximate 100 mile radius of BNHH.
  • They are able to converse in English, without the assistance of others.
  • They are deemed able to independently make an informed decision whether or not to participate in the study (i.e. the individual must appear able to understand, retain and use or weigh up information as part of decision making processes)

排除标准

  • Potential participants are excluded if they have had a previous diagnosis of cancer.
  • Potential participants are also excluded if they have had, or are due to have, a treatment of systemic chemotherapy.

结局指标

主要结局

To gather an in-depth understanding of the experiences of patients following complete cytoreductive surgery, using interpretative phenomenological analysis

时间窗: 1 Year

The primary objective of the study is to elicit an in-depth understanding of the lived experience of 'recovery' in the year following CCRS. Up to ten study participants will be interviewed on up to six occasions, and the data produced will be analysed using interpretative phenomenological analysis.

To gather an in-depth understanding of the meaning of recovery to patients after complete cytoreductive surgery, using interpretative phenomenological analysis

时间窗: 1 Year

The secondary objective of the study is to identify the meaning(s) of 'recovery' to study participants over time in the year following CCRS. Up to ten study participants will be interviewed on up to six occasions, and the data produced will be analysed using interpretative phenomenological analysis.

次要结局

未报告次要终点

研究者

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

Samuel Downes

Clinical Doctoral Research Fellowship

University of Southampton

研究点 (1)

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