Ovarian Cancer Clinical Trial
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
Summary
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.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
Madison Wisconsin, 53792, United States
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