Anxiety and Distress Levels in Women With Suspected Endometrial Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813719
• Other study ID #: 16HH3687 Psych Study EC
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: July 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Anyone lacking capacity.

• <18years old.

• Pregnant.

• Anyone unable to understand English (in absence of translator)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Psychological
• Stress
• Uterine Cancer
• Uterine Neoplasms

Locations

Country	Name	City	State
United Kingdom	Queen Charlotte and Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Score for Patients Attending Clinic	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	Immediately before clinic (waiting room)
Secondary	Pain Score if Needing a Tissue Biopsy	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.	Immediately after tissue sample taken.
Secondary	Time Taken for Tissue Sample to be Performed	Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.	During tissue biopsy time