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

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Cancer, Cervix Uteri Nos, Gestational Trophoblastic Disease

Intervention / Treatment
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* Behavioral: questionnaire
* Behavioral: questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>30 patients survived GTD post treatment for 0 - 5 years. | Behavioral: questionnaire<br>* 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<br>|
| 2<br>30 patients survived GTD post treatment 6 - 10+ years. | Behavioral: questionnaire<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GTD survivors, questionnaires, GTD