Overview

This trial is active, not recruiting.

Conditions uterine cancer, cervix uteri nos, gestational trophoblastic disease
Treatments questionnaire
Sponsor Memorial Sloan Kettering Cancer Center
Start date June 2008
End date June 2017
Trial size 60 participants
Trial identifier NCT00706875, 08-040

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
30 patients survived GTD post treatment for 0 - 5 years.
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
30 patients survived GTD post treatment 6 - 10+ years.
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

Primary Outcomes

Measure
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).
time frame: conclusion of the study

Secondary Outcomes

Measure
To describe the prevalence of premature menopause and increased bone loss through the Menopausal Symptom Check List and medical follow-up information.
time frame: conclusion of the study

Eligibility Criteria

Female participants from 18 years up to 60 years old.

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:

Additional Information

Official title A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors
Principal investigator Elizabeth Jewell, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.