A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors

Uterine Cancer Clinical Trial

Official title:

A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706875
• Other study ID #: 08-040
• Status: Completed
• Start date: June 2008
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect information on the effects of treatment for gestational trophoblastic disease (GTD). We plan to use the findings from this study to better understand GTD survivors' health and quality of life.

We would like to know more about the health, quality of life and pregnancies of women treated for GTD. This information will be used to try and improve the treatments for women who have this disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Pathology confirmed GTD by MSKCC

• Sufficient proficiency in the English language to respond to quality of life surveys

• Age = 18 years

• Benign or malignant disease

• Treated with surgery and/or chemotherapy or observation

Exclusion Criteria:

Related Conditions & MeSH terms

• Cervix Uteri Nos
• Gestational Trophoblastic Disease
• Uterine Cancer
• Uterine Neoplasms

Intervention

Behavioral:
• questionnaire
A patient questionnaire, which includes validated instruments. Data collection methods are as follows: In person at the medical appointment Over the telephone Mailed with self-addressed return envelope and prepaid postage E-mailed and returned by e-mail, fax or self-addressed envelope and pre-paid postage
• questionnaire
A patient questionnaire, which includes validated instruments. Data collection methods are as follows: In person at the medical appointment Over the telephone Mailed with self-addressed return envelope and prepaid postage E-mailed and returned by e-mail, fax or self-addressed envelope and pre-paid postage

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcomes include reproductive concerns (as measured by the Reproductive Concern Scale, RCS) and sexual functioning (as measured by the Female Sexual Function Index, FSFI).		conclusion of the study
Secondary	To describe the prevalence of premature menopause and increased bone loss through the Menopausal Symptom Check List and medical follow-up information.		conclusion of the study

External Links

•   Memorial Sloan Kettering Cancer Center