Sexual Functioning After Primary Treatment of Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00596544
First received: January 8, 2008
Last updated: October 29, 2013
Last verified: October 2013

January 8, 2008
October 29, 2013
November 2004
November 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00596544 on ClinicalTrials.gov Archive Site
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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sexual Functioning After Primary Treatment of Ovarian Cancer
Sexual Functioning After Primary Treatment of Ovarian Cancer

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?

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

MSKCC clinic

  • Ovarian Cancer
  • Sexual Dysfunction
  • Behavioral: 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
  • Behavioral: 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.
  • 1
    FSFI score <= 26
    Intervention: Behavioral: questionnaires
  • 2
    FSFI score >26
    Intervention: Behavioral: questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00596544
04-124
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Elizabeth Jewell, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP