Clinical trial NCT03813719: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Cancer
Uterine Cancer
Anxiety
Stress
Psychological
Keywords: endometrial cancer
cancer
uterine cancer
anxiety
stress
psychological
survey
point-of-care
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women attending Rapid access gynaecology clinic in imperial College NHS trust

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.

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)

Primary outcomes:
measure: Anxiety Score for Patients Attending Clinic
timeFrame: Immediately before clinic (waiting room)
Secondary outcomes:
measure: Pain Score if Needing a Tissue Biopsy
timeFrame: Immediately after tissue sample taken.
measure: Time Taken for Tissue Sample to be Performed
timeFrame: During tissue biopsy time
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Charlotte and Hammersmith Hospital
Study officials:
References: