Sexual Functioning After Primary Treatment of Ovarian Cancer
NCT ID: NCT00596544
Last Updated: 2015-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
18 participants
OBSERVATIONAL
2004-11-30
2015-11-30
Brief Summary
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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?
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
FSFI score \<= 26
questionnaires
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
2
FSFI score \>26
questionnaires
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.
Interventions
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questionnaires
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
questionnaires
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Jewell, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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04-124
Identifier Type: -
Identifier Source: org_study_id