Anxiety and Distress Levels in Women With Suspected Endometrial Cancer

Completed

• Conditions: Stress; Endometrial Cancer; Uterine Cancer; Anxiety; Cancer; Psychological

• Registration Number: NCT03813719
• Lead Sponsor: Imperial College London

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-21
• Study First Posted: 2019-01-23
• Primary Completion: 2019-07-01
• Study Completion: 2019-08-01
• Results First Submitted: 2020-06-05
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Results First Posted: 2020-07-14
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety Score for Patients Attending Clinic	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

Secondary Outcome Measures

Name	Time	Method
Pain Score if Needing a Tissue Biopsy	Immediately after tissue sample taken.	Patients asked to rank Pain score (using visual analogue score standardised tool), 0 to 10 score, where 0 is no pain and 10 is the worst pain in their life.
Time Taken for Tissue Sample to be Performed	During tissue biopsy time	Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.

Trial Locations

Locations (1)

Queen Charlotte and Hammersmith Hospital; 🇬🇧 London, United Kingdom