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

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00525460
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

* 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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To survey young women diagnosed with ovarian cancer who have undergone fertility sparing surgery on issues such as fertility counseling, post treatment decision making and reproductive history.	36 months

Secondary Outcome Measures

Name	Time	Method
To determine the feasibility of the Fertility-Sparing Survey included in this study.	36 months
To determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.	36 months

Trial Locations

Locations (3)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States