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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525460
• Other study ID #: 05-382
• Status: Completed
• Start date: April 2006
• Est. completion date: December 2014

Study information

• Verified date: July 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Fertility-Sparing Survey
A questionnaire completed either in the clinic or at home

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.		36 months
Secondary	To determine the feasibility of the Fertility-Sparing Survey included in this study.		36 months