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

July 26, 2018 updated by: Susana M. Campos, MD, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Ovarian Cancer

Intervention / Treatment

Behavioral: Fertility-Sparing Survey

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02115
    - Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women 40 years of age or younger when diagnosed with ovarian cancer who chose to have surgery that allowed them to keep their reproductive organs

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	36 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Investigators

Principal Investigator: Susana Campos, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)