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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Dana-Farber Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00525460
First received: September 4, 2007
Last updated: November 30, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Ovarian Cancer
 Behavioral: Fertility-Sparing Survey

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: April 2006
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Fertility-Sparing Survey
    A questionnaire completed either in the clinic or at home
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525460

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Susana Campos, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Susana Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00525460     History of Changes
Other Study ID Numbers: 05-382
Study First Received: September 4, 2007
Last Updated: November 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
fertility
stage I ovarian cancer
stage II ovarian cancer
fertility sparing

Additional relevant MeSH terms:
Infertility
Ovarian Neoplasms
Genital Diseases, Male
Genital Diseases, Female
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 23, 2013