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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00525460
First received: September 4, 2007
Last updated: February 19, 2014
Last verified: February 2014

September 4, 2007
February 19, 2014
April 2006
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00525460 on ClinicalTrials.gov Archive Site
  • To determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • To determine the feasibility of the Fertility-Sparing Survey included in this study. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • To determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.
  • To determine the feasibility of the Fertility-Sparing Survey included in this study.
Not Provided
Not Provided
 
Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function
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.

  • 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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Ovarian Cancer
Behavioral: Fertility-Sparing Survey
A questionnaire completed either in the clinic or at home
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00525460
05-382
No
Susana M. Campos, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
Principal Investigator: Susana Campos, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP