Expired Study
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Madison, Wisconsin 53792


Purpose:

This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.


Study summary:

PRIMARY OBJECTIVES: I. To evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants. II. To determine the distribution of candidate primary patient‐reported outcome measures, including time to resumption of sexual activity, global satisfaction with sex life, sexual function and anxiety in this particular population. III. To establish the prevalence of patient recall of the intervention to determine the most effective time at which to deliver the intervention. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit. ARM II: Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit. ARM III: Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit. ARM IV: Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.


Criteria:

Inclusion Criteria: - Patients with a new suspected or confirmed gynecologic malignancies - Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital - Patients must be English speaking Exclusion Criteria: - Previous treatment of any cancer excluding skin cancer - Patients with a suspected benign gynecologic process - Patients who are prisoners or incarcerated


NCT ID:

NCT02096783


Primary Contact:

Principal Investigator
David Kushner
University of Wisconsin, Madison


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53792
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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