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

• ClinicalTrials.gov Identifier: NCT00525460
• Recruitment Status: Completed
• First Posted: September 5, 2007
• Last Update Posted: July 27, 2018
• Sponsor: Dana-Farber Cancer Institute
• 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.

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

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

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