Sexual Functioning After Primary Treatment of Ovarian Cancer - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00596544

Purpose

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?

Condition	Intervention
Ovarian Cancer Sexual Dysfunction	Behavioral: questionnaires

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Sexual Functioning After Primary Treatment of Ovarian Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	November 2004
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 FSFI score <= 26	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
2 FSFI score >26	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.

Groups/Cohorts

Assigned Interventions

1

FSFI score <= 26

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

2

FSFI score >26

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

MSKCC clinic

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596544

Contacts

Contact: Martee Hensley, MD		hensleym@mskcc.org
Contact: Jeanne Carter, PhD		carterj@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Martee Hensley, MD hensleym@mskcc.org
Contact: Jeanne Carter, PhD carterj@mskcc.org
Principal Investigator: Martee Hensley, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Martee Hensley, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Martee Hensley, MD )
Study ID Numbers:	04-124
Study First Received:	January 8, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00596544
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

sexual dysfunction

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009