Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function

NCT ID: NCT00525460

Last Updated: 2018-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to ask youn women diagnosed with ovarian cancer who have undergone surgery that will allow them to have children in the future, on issues such as: education about their options to keep their ability to have children, after-chemotherapy treatment decision making, and reproductive history. The second purpose is to determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.

Detailed Description

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* Participants will be asked to complete a questionnaire either in the clinic or at home and return it to the research staff by mail or in person.
* The study will involve being asked questions about the following: Fertility history; sexual history after being diagnosed with cancer; decision to have surgery that will allow them to have children; education they may or may not have received about the surgery that saved their ability to have children.
* Answers to all questions will be kept confidential and participants will be identified by a number only.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Fertility-Sparing Survey

A questionnaire completed either in the clinic or at home

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women diagnosed with stage I or II invasive ovarian cancer, that underwent fertility sparing surgery
* Women who were premenopausal prior to diagnosis
* 40 years of age or younger at the time of ovarian cancer diagnosis
* Completed therapy for early stage cancer
* No evidence of recurrence
* No history fo known infertility prior to diagnosis
* No other significant medical conditions that would affect fertility
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Susana M. Campos, MD

Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susana Campos, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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05-382

Identifier Type: -

Identifier Source: org_study_id

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