Sexual Functioning After Primary Treatment of Ovarian Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00596544
First received: January 8, 2008
Last updated: October 29, 2012
Last verified: October 2012
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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 2013 |
| Estimated Primary Completion Date: | November 2013 (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, 2012 |
| 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 May 22, 2013