NCT00596544TerminatedNot Applicable
Sexual Functioning After Primary Treatment of Ovarian Cancer
Memorial Sloan Kettering Cancer Center1 site in 1 country18 target enrollmentStarted: November 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- To estimate the prevalence of sexual dysfunction, as measured by Female Sexual Functioning Index (FSFI) among women who have completed first-line treatment for ovarian cancer within the last 6 months and currently have no evidence of disease.
Study Overview
Brief Summary
The purpose of this study is to help us learn more about sexual problems after treatment for ovarian cancer. At this time, we do not know how many women have sexual problems after they are treated for ovarian cancer.
How common are sexual problems after treatment for ovarian cancer?
- What factors make women more likely to have sexual problems after treatment for ovarian cancer?
- What happens to sexual functioning over the first 12 months after treatment? ie.
Does it get better or worse?
• Does referral to a specialized sexual health clinic help?
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women with any stage of invasive epithelial ovarian cancer who have completed frontline therapy within the past 6 months
- •Women must have no clinical evidence of disease
- •At least 18 years of age
- •English speaking
- •Able to participate in the informed consent process
- •Women who present to Sexual Health Clinic for the first time and meet all other eligibility criteria are eligible. Their FSFI scores will be used to determine the primary endpoint of prevalence of sexual dysfunction. If they score over 26 on the FSFI, they may still elect to be followed at the SHC.
Exclusion Criteria
- •Active secondary cancer requiring cytotoxic chemotherapy at the time enrollment
- •Evidence of recurrent/persistent disease by elevated CA125, findings on imaging (CT, PET scan etc) or physical examination
- •Women with borderline (low malignant potential) ovarian cancers
- •Women who are already in active evaluation and/or follow-up at the Sexual Health Clinic
- •Women with a history of prior whole pelvic radiation
Outcomes
Primary Outcomes
To estimate the prevalence of sexual dysfunction, as measured by Female Sexual Functioning Index (FSFI) among women who have completed first-line treatment for ovarian cancer within the last 6 months and currently have no evidence of disease.
Time Frame: conclusion of study
Secondary Outcomes
- To study the natural history of sexual functioning in women after primary treatment of ovarian cancer by using the FSFI at approximately 3, 6 and 12 months.(conclusion of study)
Investigators
Study Sites (1)
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