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NCT03813719

Anxiety and Distress Levels in Women With Suspected Endometrial Cancer

Completed Results posted Last updated 14 July 2020
What this trial tests

trial in Endometrial Cancer in 250 participants. Completed in 1 August 2019.

Timeline
1 July 2018
Primary endpoint
1 July 2019
1 August 2019

Quick facts

Lead sponsorImperial College London
StatusCompleted
Study typeOBSERVATIONAL
Enrollment250
Start date1 July 2018
Primary completion1 July 2019
Estimated completion1 August 2019
Sites1 location across United Kingdom

Conditions studied

Sponsor

Imperial College London

Who can join

18 and older, female only, with Endometrial Cancer or Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Anxiety Score for Patients Attending Clinic Primary · 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

GroupValue95% CI
All Patients Attending Rapid Access Gynaecology Clinic63 – 12
Pain Score if Needing a Tissue Biopsy Secondary · 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.

GroupValue95% CI
All Patients Attending Rapid Access Gynaecology Clinic5.53 – 8
Time Taken for Tissue Sample to be Performed Secondary · During tissue biopsy time

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

GroupValue95% CI
All Patients Attending Rapid Access Gynaecology Clinic5.53 – 8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Endometrial Cancer

Currently open trials in the same condition.

Other Imperial College London trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03813719.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing