Clinical trial NCT00525460: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: fertility
stage I ovarian cancer
stage II ovarian cancer
fertility sparing
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2007-09-05
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
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.
timeFrame: 36 months
Secondary outcomes:
measure: To determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.
timeFrame: 36 months
measure: To determine the feasibility of the Fertility-Sparing Survey included in this study.
timeFrame: 36 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Susana Campos, MD
role: PRINCIPAL_INVESTIGATOR
References: