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临床试验/NCT04444544
NCT04444544已完成不适用

Changes of Health-related Quality of Life 6 Months After High-risk Oncological Upper Gastrointestinal and Hepatobiliary Surgery: a Single-centre Prospective Observational Study (ChangeQol Study)

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 295 人开始时间: 2020年9月5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
295
试验地点
2
主要终点
Health-related Quality of Life

研究概览

简要总结

The investigators plan to measure the changes of health-related quality of life (HRQoL) at 6 months and 12 months after the following high-risk oncological abdominal surgery: gastrectomy, esophagectomy, pancreatectomy and hepatectomy. The investigators will measure the HRQoL using the validated EORTC QLQ-C30 questionnaire before and at 6 months and 12 month after the surgery. The investigators will identify phenotypes of HRQoL changes (improvement, stability and deterioration) at 6 months and 12 months after surgery.

The second aim is to assess the regret of the patient at 6 months and 12 months regarding his/her decision to undergo surgery. The investigators will also assess the regret of the next of kin at 6 months regarding the decision to undergo surgery.

This descriptive, prospective, observational, single-centre cohort study aims to: identify phenotypes of HRQoL changes after abdominal surgical oncology (improvement, stability and deterioration); assess the regret of patients regarding their decision to undergo surgical oncology at 6 months and 12 months; assess the regret of the next of kin regarding the decision of the patient to undergo surgical oncology at 6 months and 12 months. The investigators will include patients scheduled for the following elective abdominal cancer surgery: gastrectomy; esophagectomy; pancreas resection and hepatectomy. The investigators will assess HRQoL using the validated EORTC QLQ-C30 Summary Score before and 6 months and 12 months after surgery. The cut-offs for the three phenotypes of HRQoL changes will be defined using the minimal clinically important difference (MCID) of 10 points. The investigators will assess regret using the Decision Regret Scale (DRS) at 6 months and 12 months after surgery.

The expected results are: The investigators can identify phenotypes of HRQoL changes after surgical oncology using the EORTC QLQ-C30 Summary Score; the investigators will describe the distribution of these phenotypes and will find an association with the pre-existing frailty. The investigators can describe the extent of the regret of the patient and of the next of kin at 6 months using the DRS. The investigators will observe an association between the DRS score at 6 months and the HRQoL Summary Score change. The investigators will not observe a relationship between the DRS score of patients and next-of-kins.

详细描述

The full protocol has been published: DOI 10.1136/bmjopen-2022-065902

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

  • - Adult patients (>18 years) scheduled for the following elective abdominal cancer surgery known for high one-year mortality4: gastrectomy; esophagectomy; pancreas resection and hepatectomy

排除标准

  • Patients with inoperable tumours; i.e. some patients will be excluded at the time of surgery if unexpected advanced tumour staging is confirmed intraoperatively (e.g. peritoneal carcinomatosis or any other diagnosis without therapy).
  • Hepatectomy for metastasectomy
  • Mentally impaired patients (known diagnosis)
  • Psychotic diagnoses (i.e. schizophrenia)
  • Dementia (mini mental score (MMSE) < 18)
  • Incapacity to understand the information sheet
  • Blindness (unable to perform the visual part of the mini-mental state examination)

结局指标

主要结局

Health-related Quality of Life

时间窗: 6 months after surgery

EORTC-QLQ C30. Minimum 0, Maximum 100

次要结局

  • Health-related Quality of Life(12 months after surgery)
  • Regret(6 and 12 months after surgery)

研究者

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

Julien Maillard

Principal Investigator

University Hospital, Geneva

研究点 (2)

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