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
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 18
Study Start Date: November 2004
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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.

  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

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Elizabeth Jewell, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00596544     History of Changes
Other Study ID Numbers: 04-124
Study First Received: January 8, 2008
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
sexual dysfunction

Additional relevant MeSH terms:
Ovarian Neoplasms
Sexual Dysfunctions, Psychological
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014