Anxiety, Cancer, Endometrial Cancer, Psychological, Stress, Uterine Cancer
Conditions
Keywords
endometrial cancer, cancer, uterine cancer, anxiety, stress, psychological, survey, point-of-care
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.
Interventions
None listed
Sponsors
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Consective patients attending Rapid access Gynaecology Clinic for the first time, with suspected endometrial cancer between July 2018 and April 2019
Participants by arm
| Arm | Count |
|---|---|
| All Patients Attending Rapid Access Gynaecology Clinic Consecutive patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer. | 250 |
| Total | 250 |
Baseline characteristics
| Characteristic | All Patients Attending Rapid Access Gynaecology Clinic |
|---|---|
| Age, Customized <30 | 13 Participants |
| Age, Customized 30-39 | 15 Participants |
| Age, Customized 40-49 | 43 Participants |
| Age, Customized 50-59 | 88 Participants |
| Age, Customized 60-69 | 56 Participants |
| Age, Customized 70-79 | 25 Participants |
| Age, Customized 80+ | 10 Participants |
| Race/Ethnicity, Customized Race/ethnicity Asian | 35 Participants |
| Race/Ethnicity, Customized Race/ethnicity Black/Afro-carribean | 34 Participants |
| Race/Ethnicity, Customized Race/ethnicity Caucasian | 141 Participants |
| Race/Ethnicity, Customized Race/ethnicity Mixed | 5 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other | 33 Participants |
| Race/Ethnicity, Customized Race/ethnicity Prefer not to say | 2 Participants |
| Region of Enrollment United Kingdom | 250 participants |
| Sex: Female, Male Female | 250 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 250 |
| other Total, other adverse events | 0 / 250 |
| serious Total, serious adverse events | 0 / 250 |
Outcome results
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
Time frame: Immediately before clinic (waiting room)
Population: GAD 7 scores were calculated for each patient
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients Attending Rapid Access Gynaecology Clinic | Anxiety Score for Patients Attending Clinic | 6 score on a scale |
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.
Time frame: Immediately after tissue sample taken.
Population: Only 23 women required a tissue biopsy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients Attending Rapid Access Gynaecology Clinic | Pain Score if Needing a Tissue Biopsy | 5.5 score on a scale |
Secondary
Time Taken for Tissue Sample to be Performed
Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.
Time frame: During tissue biopsy time
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Patients Attending Rapid Access Gynaecology Clinic | Time Taken for Tissue Sample to be Performed | 5.5 Minutes |