Patient's Experience and Choice Between Investigations for Endometrial Cancer in Postmenopausal Bleeding

NCT03330015 | Completed DMC

• 1 other identifier: CREC 2015.437
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Endometrial cancer is the most common malignancy of the female genital tract in Hong Kong. The aim in the evaluation of PMB is to exclude underlying malignancy. Endometrial thickness (ET) measured by transvaginal ultrasound scanning (TVS) and endometrial biopsy or sampling (ES) has been recommended as the first-line investigation. From a study between 2002-2013 in the One-stop PMB clinic, investigators found that ET was able to identify women with endometrial cancer with the sensitivity at 3mm, 4mm, and 5mm, the current levels recommended in professional guidelines, being 97.0%, 94.1%, and 93.5% respectively. However, little is known about the level of patient's acceptance of the false negative rate and how patient would trade residual risk with more invasive test. There is also a lack of study on the experience of women during the management pathway especially the level of anxiety before and after investigations and the pain experienced from the investigations offered. The current study aim to study the level of false negative rate accepted by women for the investigation of PMB and the level of anxiety and pain experienced during the investigation pathway.

Conditions

Endometrial Cancer; Postmenopausal Bleeding

Keywords

postmenopausal bleeding; endometrial cancer; Patient's experience; Patient's choice

Outcome Measures

Primary Outcomes (1)

• The level of acceptance of false negative rate using TVS ET

  The level of acceptance of false negative rate using endometrial thickness assessed by transvaginal ultrasound scanning to identify endometrial cancer.

  Baseline

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our center provides a dedicated Postmenopausal Bleeding Clinic for the one-stop evaluation for PMB in Hong Kong and we receive referrals from other centers in Hong Kong. Our center is a tertiary-care university institution with two affiliated hospitals.All patients who are new referrals for the symptom of PMB will be invited to participate in the study. A woman is considered to have PMB if there is occurrence of bleeding after one completed year of amenorrhoea.

You may qualify if:

• postmenopausal woman
• referrals for the symptom of PMB

You may not qualify if:

• dementia
• mental retardation

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Wen Ying Fung

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 6, 2017
• Study Start: June 3, 2016
• Primary Completion: June 26, 2017
• Study Completion: September 26, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-09

Locations

HK (1)