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Clinical Trials/NCT00525460
NCT00525460
Completed
Not Applicable

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

Dana-Farber Cancer Institute3 sites in 1 country16 target enrollmentApril 2006
ConditionsOvarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
Dana-Farber Cancer Institute
Enrollment
16
Locations
3
Primary Endpoint
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.
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
December 2014
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susana M. Campos, MD

Medical Oncologist

Dana-Farber Cancer Institute

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Time Frame: 36 months

Secondary Outcomes

  • 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)

Study Sites (3)

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