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
1 other identifier
observational
16
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2006
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 4, 2007
CompletedFirst Posted
Study publicly available on registry
September 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 27, 2018
July 1, 2018
8.7 years
September 4, 2007
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
36 months
Secondary Outcomes (2)
To determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.
36 months
To determine the feasibility of the Fertility-Sparing Survey included in this study.
36 months
Interventions
A questionnaire completed either in the clinic or at home
Eligibility Criteria
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
You may qualify if:
- Women diagnosed with stage I or II invasive ovarian cancer, that underwent fertility sparing surgery
- Women who were premenopausal prior to diagnosis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Beth Israel Deaconess Medical Centercollaborator
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susana Campos, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Oncologist
Study Record Dates
First Submitted
September 4, 2007
First Posted
September 5, 2007
Study Start
April 1, 2006
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 27, 2018
Record last verified: 2018-07