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

NCT00706875 | Completed

• 1 other identifier: 08-040
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cancer; Cervix Uteri Nos; Gestational Trophoblastic Disease

Keywords

GTD survivors; questionnaires; GTD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

30 patients survived GTD post treatment for 0 - 5 years.

Behavioral: questionnaire

2

30 patients survived GTD post treatment 6 - 10+ years.

Behavioral: questionnaire

Interventions

questionnaire BEHAVIORAL

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

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Uterine Neoplasms; Gestational Trophoblastic Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Pregnancy Complications, Neoplastic; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Elizabeth Jewell, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

US (1)