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Sexual Functioning After Primary Treatment of Ovarian Cancer

Sexual Functioning After Primary Treatment of Ovarian Cancer

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00596544
Enrollment
18
Registered
2008-01-17
Start date
2004-11-30
Completion date
2015-11-30
Last updated
2015-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Sexual Dysfunction

Keywords

sexual dysfunction

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?

Interventions

BEHAVIORALquestionnaires

will be offered referral to the Sexual Health Clinic (SHC) at MSKCC for evaluation and possible treatment. The effectiveness and compliance of the intervention offered at the SHC will be assessed at approximately 3, 6 and 12 months using the FSFI, SAQ, CES-D, MSC and IES. At each evaluation they will complete a Health Surveillance Form (HSF). They will have completed the study at 12 months after entering the study or at the time they have evidence of recurrent disease requiring treatment

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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.conclusion of study

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026