Clinical Trials Directory

Trials / Completed

CompletedNCT03813719

Anxiety and Distress Levels in Women With Suspected Endometrial Cancer

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

Status
Completed
Phase
Study type
Observational
Enrollment
250 (actual)
Sponsor
Imperial College London · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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. Once the endometrial biopsy is performed, it is sent to the histologist for further examination. Histological analysis may take several days and patients are either brought back to clinic for discussion of the results or are given a telephone appointment. The patient often will not know the result of the test for up to 2 weeks; thus causing a lot of unnecessary anxiety and distress. The study: Patients attending the Rapid Access Gynaecology Clinic will be invited to participate in the study by filling in a short anonymous survey. Additionally, patients undergoing a tissue biopsy sample will be asked to provide a pain score, followed by a brief interview to ascertain if they would undergo the procedure again if it was needed and how they tolerated the procedure. Additionally, the time taken to perform the procedure will be recorded.

Conditions

Timeline

Start date
2018-07-01
Primary completion
2019-07-01
Completion
2019-08-01
First posted
2019-01-23
Last updated
2020-07-14
Results posted
2020-07-14

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03813719. Inclusion in this directory is not an endorsement.