Brief Title
Anxiety and Distress Levels in Women With Suspected Endometrial Cancer
Official Title
Anxiety and Distress Levels in Women With Suspected Endometrial Cancer Seen in the Rapid Access Gynaecology Clinic
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.
Study Type
Observational
Primary Outcome
Anxiety Score for Patients Attending Clinic
Secondary Outcome
Pain Score if Needing a Tissue Biopsy
Condition
Endometrial Cancer
Study Arms / Comparison Groups
All patients attending Rapid access Gynaecology Clinic
Description: All patients attending Rapid access Gynaecology Clinic for the first time.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
250
Start Date
July 1, 2018
Completion Date
August 1, 2019
Primary Completion Date
July 1, 2019
Eligibility Criteria
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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03813719
Organization ID
16HH3687 Psych Study EC
Responsible Party
Sponsor
Study Sponsor
Imperial College London
Study Sponsor
, ,
Verification Date
July 2020