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临床试验/NCT03813719
NCT03813719已完成不适用

Anxiety and Distress Levels in Women With Suspected Endometrial Cancer Seen in the Rapid Access Gynaecology Clinic

Imperial College London1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年7月1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
250
试验地点
1
主要终点
Anxiety Score for Patients Attending Clinic

研究概览

简要总结

Patients attending the rapid access gynaecology clinic with a suspicion of endometrial cancer are understandably nervous. Few studies have quantified anxiety and distress of patients in this group.

This study surveys anxiety and stress levels of women attending clinic (by filling in an anonymous questionnaire). Additionally, in women who need a tissue biopsy, women are asked to rate their pain scores.

详细描述

Aims:

Quantify the anxiety and stress levels of women attending the Rapid access gynaecology clinic with a suspicion of cancer

Background:

Endometrial cancer is a tumour originating in the endometrium (womb lining); it is the most common gynaecological cancer in the United Kingdom (UK). In 2012, there were almost 100,000 new cases diagnosed in Europe. Endometrial cancer classically presents with postmenopausal bleeding (bleeding after the menopause), or intermenstrual bleeding (bleeding in between periods).

Although routine management for these women does vary, in general a screening test is performed, typically a pelvic (internal) ultrasound to assess the endometrium (womb lining). In cases where the endometrial thickness is above the threshold for investigation -an endometrial biopsy (sampling cells from the womb lining) is indicated. Whilst well tolerated, this can be quite painful.

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
Female
接受健康志愿者

入选标准

  • All women presenting to rapid access gynaecology clinic with suspected gynaecological cancer

排除标准

  • Anyone lacking capacity.
  • <18years old.
  • Pregnant.
  • Anyone unable to understand English (in absence of translator)

结局指标

主要结局

Anxiety Score for Patients Attending Clinic

时间窗: Immediately before clinic (waiting room)

GAD 7 score - (Generalised Anxiety Disorder assessment 7 score). 7 items each measured and score summated. Scale 0-21.Cut offs 0-5, 6-10, 11-15, 16+ correlate with anxiety score. Higher levels = worse anxiety

次要结局

  • Pain Score if Needing a Tissue Biopsy(Immediately after tissue sample taken.)
  • Time Taken for Tissue Sample to be Performed(During tissue biopsy time)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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