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

Completed

• Conditions: Uterine Cancer; Cervix Uteri Nos; Gestational Trophoblastic Disease
• Interventions: Behavioral: questionnaire

• Registration Number: NCT00706875
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-06-30
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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

Read More

Exclusion Criteria

• None

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	questionnaire	30 patients survived GTD post treatment for 0 - 5 years.
2	questionnaire	30 patients survived GTD post treatment 6 - 10+ years.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States