Sexual Functioning After Primary Treatment of Ovarian Cancer

Study Overview
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Brief Summary
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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?

Official Title
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Sexual Functioning After Primary Treatment of Ovarian Cancer

Conditions
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Ovarian Cancer, Sexual Dysfunction

Intervention / Treatment
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* Behavioral: questionnaires
* Behavioral: questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>FSFI score <= 26 | Behavioral: questionnaires<br>* 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<br>|
| 2<br>FSFI score >26 | Behavioral: questionnaires<br>* Those women who have a FSFI score > 26 will be reassessed at approximately 3, 6 and 12 months. They will complete the FSFI, SAQ, CES-D, IES, MSC and HSF at each assessment. They will be followed out until 12 months after entering the study or until they have evidence of recurrent disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexual dysfunction