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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients attending Rapid access Gynaecology Clinic | All patients attending Rapid access Gynaecology Clinic for the first time. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Time Taken for Tissue Sample to be Performed |
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Inclusion Criteria:
Exclusion Criteria:
Study on suspected endometrial cancer
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All women attending Rapid access gynaecology clinic in imperial College NHS trust
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Charlotte and Hammersmith Hospital | London | W12 0HS | United Kingdom |
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Consective patients attending Rapid access Gynaecology Clinic for the first time, with suspected endometrial cancer between July 2018 and April 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients Attending Rapid Access Gynaecology Clinic | All patients attending Rapid access Gynaecology Clinic for the first time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients recruited from 2 London hospitals
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients Attending Rapid Access Gynaecology Clinic | Consecutive patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | GAD 7 scores were calculated for each patient | Posted | Median | Inter-Quartile Range | score on a scale | Immediately before clinic (waiting room) |
|
|
Survey and paired observational study. No additional interventions performed (pipelle biopsies were part of standard of care) so adverse effects specifically due to study should be zero. Having said that, the time and pain score for pipelle biopsies were observed and recorded as part of this study and complications for pipelle biopsy were recorded. Any complications for a tissue biopsy would be apparent immediately, so time frame post biopsy 20 minutes.
Survey and Observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients Attending Rapid Access Gynaecology Clinic | All patients attending Rapid access Gynaecology Clinic for the first time. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Diana Marcus | Imperial College London | 07525133957 | d.marcus16@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2017 | Jun 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009369 | Neoplasms |
| D014594 | Uterine Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
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Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum. |
| During tissue biopsy time |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 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. | Only 23 women required a tissue biopsy | Posted | Median | Inter-Quartile Range | score on a scale | Immediately after tissue sample taken. |
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|
|
| Secondary | Time Taken for Tissue Sample to be Performed | Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum. | Posted | Mean | Inter-Quartile Range | Minutes | During tissue biopsy time |
|
|
|
| 0 |
| 250 |
| 0 |
| 250 |
| 0 |
| 250 |
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001523 | Mental Disorders |