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Trial record 2 of 123 for:    FOCUS | Ovarian Cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00525460
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : July 27, 2018
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

Tracking Information
First Submitted Date September 4, 2007
First Posted Date September 5, 2007
Last Update Posted Date July 27, 2018
Study Start Date April 2006
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2007)
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 ]
Original Primary Outcome Measures
 (submitted: September 4, 2007)
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.
Change History
Current Secondary Outcome Measures
 (submitted: December 19, 2007)
  • To determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women. [ Time Frame: 36 months ]
  • To determine the feasibility of the Fertility-Sparing Survey included in this study. [ Time Frame: 36 months ]
Original Secondary Outcome Measures
 (submitted: September 4, 2007)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function
Official Title A Pilot Study of Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Ovarian Cancer
Intervention Behavioral: Fertility-Sparing Survey
A questionnaire completed either in the clinic or at home
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 3, 2015)
16
Original Estimated Enrollment
 (submitted: September 4, 2007)
20
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00525460
Other Study ID Numbers 05-382
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Susana M. Campos, MD, Dana-Farber Cancer Institute
Original Responsible Party Not Provided
Current Study Sponsor Dana-Farber Cancer Institute
Original Study Sponsor Same as current
Collaborators
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
Investigators
Principal Investigator: Susana Campos, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date July 2018