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Development and Validation of EHP-30 (Hong Kong Chinese Version) for Patients With Endometriosis and Adenomyosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03302468
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Fung Wen Ying Linda, Chinese University of Hong Kong

Brief Summary:

Endometriosis and adenomyosis can impact on the quality of life including the physical, psychological and social aspects. It is important to include quality of life measurements in evaluating the disease severity and response to any given treatment. The 30-item Endometriosis Health Profile (EHP-30), derived from in-depth interviews of patients with endometriosis, is currently the most reliable questionnaire for health-related quality of life measurement in women with endometriosis. It includes specific questions addressing the problems faced by patients with endometriosis.

Unfortunately, this widely accepted tool does not have a traditional Chinese version for the measurement of health-related quality of life of endometriosis in Hong Kong. Furthermore, adenomyosis and endometriosis share similar histological and clinical symptomatology, but application of EHP-30 to adenomyosis has never been studied.

The aims of the present study are to translate the EHP-30 English version into traditional Chinese version and to evaluate its psychometric properties in endometriosis and adenomyosis.

The hypothesis of this study is that EHP-30 (Hong Kong) traditional Chinese questionnaire has high internal consistency, construct validity, reproducibility as the original English version and can be applicable to Hong Kong Chinese women with endometriosis and adenomyosis.


Condition or disease
Endometriosis Adenomyosis

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Study Type : Observational
Estimated Enrollment : 444 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of the Endometriosis Health Profile-30 Traditional Chinese (Hong Kong) Version in Endometriosis and Adenomyosis
Actual Study Start Date : August 6, 2015
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis




Primary Outcome Measures :
  1. Validation of Endometriosis health profile-30 (EHP-30) traditional Chinese (Hong Kong) version [ Time Frame: Baseline ]
    internal consistency and construct validity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Eligible Chinese women attending the Gynaecology clinic of New Territories East Cluster will be invited to join the study.
Criteria

Inclusion Criteria:

  • Premenopausal
  • Hong Kong Chinese women
  • diagnosed with endometriosis or adenomyosis.

Exclusion Criteria:

  • uterine fibroid more than 5 cm
  • other premalignant or malignant conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302468


Contacts
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Contact: Wen Ying Fung 852-35052748 lindafung@cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Wen Ying Fung    852-35052748    lindafung@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Wen Ying Fung 852-35052748
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Responsible Party: Fung Wen Ying Linda, Associate Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03302468    
Other Study ID Numbers: EHP30 traditional Chinese
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Endometriosis
Adenomyosis
Uterine Diseases