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Trial Outcomes & Findings for Anxiety and Distress Levels in Women With Suspected Endometrial Cancer (NCT NCT03813719)

NCT ID: NCT03813719

Last Updated: 2020-07-14

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

250 participants

Primary outcome timeframe

Immediately before clinic (waiting room)

Results posted on

2020-07-14

Participant Flow

Consective patients attending Rapid access Gynaecology Clinic for the first time, with suspected endometrial cancer between July 2018 and April 2019

Participant milestones

Participant milestones
Measure
All Patients Attending Rapid Access Gynaecology Clinic
All patients attending Rapid access Gynaecology Clinic for the first time.
Overall Study
STARTED
250
Overall Study
COMPLETED
250
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anxiety and Distress Levels in Women With Suspected Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Patients Attending Rapid Access Gynaecology Clinic
n=250 Participants
Consecutive patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
Age, Customized
<30
13 Participants
n=5 Participants
Age, Customized
30-39
15 Participants
n=5 Participants
Age, Customized
40-49
43 Participants
n=5 Participants
Age, Customized
50-59
88 Participants
n=5 Participants
Age, Customized
60-69
56 Participants
n=5 Participants
Age, Customized
70-79
25 Participants
n=5 Participants
Age, Customized
80+
10 Participants
n=5 Participants
Sex: Female, Male
Female
250 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/ethnicity · Caucasian
141 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/ethnicity · Black/Afro-carribean
34 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/ethnicity · Asian
35 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/ethnicity · Mixed
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/ethnicity · Other
33 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/ethnicity · Prefer not to say
2 Participants
n=5 Participants
Region of Enrollment
United Kingdom
250 participants
n=5 Participants

PRIMARY outcome

Timeframe: Immediately before clinic (waiting room)

Population: GAD 7 scores were calculated for each patient

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

Outcome measures

Outcome measures
Measure
All Patients Attending Rapid Access Gynaecology Clinic
n=250 Participants
All patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
Anxiety Score for Patients Attending Clinic
6 score on a scale
Interval 3.0 to 12.0

SECONDARY outcome

Timeframe: Immediately after tissue sample taken.

Population: Only 23 women required 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.

Outcome measures

Outcome measures
Measure
All Patients Attending Rapid Access Gynaecology Clinic
n=23 Participants
All patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
Pain Score if Needing a Tissue Biopsy
5.5 score on a scale
Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: During tissue biopsy time

Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.

Outcome measures

Outcome measures
Measure
All Patients Attending Rapid Access Gynaecology Clinic
n=23 Participants
All patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.
Time Taken for Tissue Sample to be Performed
5.5 Minutes
Interval 3.0 to 8.0

Adverse Events

All Patients Attending Rapid Access Gynaecology Clinic

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Diana Marcus

Imperial College London

Phone: 07525133957

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place