A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00706875

Purpose

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.

Condition	Intervention
Uterine Cancer Cervix Uteri Nos Gestational Trophoblastic Disease	Behavioral: questionnaire

MedlinePlus related topics: Cancer Uterine Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 30 patients survived GTD post treatment for 0 - 5 years.	Behavioral: questionnaire A patient questionnaire, which includes validated instruments, will be given to participants. Data will be collected during clinic visits, through mailed surveys or over the telephone.
2 30 patients survived GTD post treatment 6 - 10+ years.	Behavioral: questionnaire A patient questionnaire, which includes validated instruments, will be given to participants. Data will be collected during clinic visits, through mailed surveys or over the telephone.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

GTD survivors treated at Memorial Sloan-Kettering Cancer Center (MSKCC).

Criteria

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:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706875

Contacts

Contact: Carol Aghajanian, MD		aghajanc@mskcc.org
Contact: Jeanne Carter, PhD		carterj@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Carol Aghajanian, MD
Contact: Jeanne Carter, MD, PhD carterj@mskcc.org
Principal Investigator: Carol Aghajanian, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Carol Aghajanian, MD )
Study ID Numbers:	08-040
Study First Received:	June 26, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00706875
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

GTD survivors
questionnaires
GTD

Study placed in the following topic categories:

Genital Diseases, Female
Gestational trophoblastic disease
Pregnancy Complications
Neoplasms, Germ Cell and Embryonal
Gestational Trophoblastic Neoplasms
Genital Neoplasms, Female

Hydatidiform Mole
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Trophoblastic Neoplasms
Nevus

Additional relevant MeSH terms:

Neoplasms
Pregnancy Complications, Neoplastic
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009