Sexual Functioning After Primary Treatment of Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Sexual Functioning After Primary Treatment of Ovarian Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00596544
• Other study ID #: 04-124
• Status: Terminated
• Phase: N/A
• First received: January 8, 2008
• Last updated: November 25, 2015
• Start date: November 2004
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Sexual Dysfunction

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center