Anxiety and Distress Levels in Women With Suspected Endometrial Cancer

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03813719
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 19.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer; Cancer; Uterine Cancer; Anxiety; Stress; Psychological

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 Design

• Study Type: Observational
• Actual Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Anxiety and Distress Levels in Women With Suspected Endometrial Cancer Seen in the Rapid Access Gynaecology Clinic
• Actual Study Start Date: Jul 1, 2018
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
All patients attending Rapid access Gynaecology Clinic All patients attending Rapid access Gynaecology Clinic for the first time.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Charlotte and Hammersmith Hospital	London		United Kingdom	W12 0HS

Sponsors and Collaborators

• Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2017

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT03813719
• Other Study ID Numbers: 16HH3687 Psych Study EC
• First Posted: Jan 23, 2019
• Last Update Posted: Jul 14, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: endometrial cancer; cancer; uterine cancer; anxiety; stress; psychological; survey; point-of-care
• Additional relevant MeSH terms: Endometrial Neoplasms; Uterine Neoplasms; Anxiety Disorders

Study Results

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

Arm/Group Title	All Patients Attending Rapid Access Gynaecology Clinic
Arm/Group Description	All patients attending Rapid access Gynaecology Clinic for the first time.
Period Title: Overall Study
STARTED	250
COMPLETED	250
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Patients Attending Rapid Access Gynaecology Clinic
Arm/Group Description	Consecutive patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
Overall Participants	250
Age, Customized (Count of Participants)
<30	13 5.2%
30-39	15 6%
40-49	43 17.2%
50-59	88 35.2%
60-69	56 22.4%
70-79	25 10%
80+	10 4%
Sex: Female, Male (Count of Participants)
Female	250 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	141 56.4%
Black/Afro-carribean	34 13.6%
Asian	35 14%
Mixed	5 2%
Other	33 13.2%
Prefer not to say	2 0.8%
Region of Enrollment (participants) [Number]
United Kingdom	250 100%

Outcome Measures

1. Primary Outcome

Title	Anxiety Score for Patients Attending Clinic
Description	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)

Outcome Measure Data

Analysis Population Description

GAD 7 scores were calculated for each patient

Arm/Group Title	All Patients Attending Rapid Access Gynaecology Clinic
Arm/Group Description	All patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
Measure Participants	250
Median (Inter-Quartile Range) [score on a scale]	6

2. Secondary Outcome

Title	Pain Score if Needing a Tissue Biopsy
Description	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.

Outcome Measure Data

Analysis Population Description

Only 23 women required a tissue biopsy

Arm/Group Title	All Patients Attending Rapid Access Gynaecology Clinic
Arm/Group Description	Consecutive patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
Measure Participants	23
Median (Inter-Quartile Range) [score on a scale]	5.5

3. Secondary Outcome

Title	Time Taken for Tissue Sample to be Performed
Description	Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.
Time Frame	During tissue biopsy time

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients Attending Rapid Access Gynaecology Clinic
Arm/Group Description	All patients attending Rapid access Gynaecology Clinic for the first time.
Measure Participants	23
Mean (Inter-Quartile Range) [Minutes]	5.5

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	Survey and Observational study.
Arm/Group Title	All Patients Attending Rapid Access Gynaecology Clinic
Arm/Group Description	All patients attending Rapid access Gynaecology Clinic for the first time.
All Cause Mortality
	All Patients Attending Rapid Access Gynaecology Clinic
	Affected / at Risk (%)	# Events
Total	0/250 (0%)
Serious Adverse Events
	All Patients Attending Rapid Access Gynaecology Clinic
	Affected / at Risk (%)	# Events
Total	0/250 (0%)
Other (Not Including Serious) Adverse Events
	All Patients Attending Rapid Access Gynaecology Clinic
	Affected / at Risk (%)	# Events
Total	0/250 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.