NCT02096783

Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer

Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Anxiety Disorder
• Cervical Cancer
• Endometrial Cancer
• Female Reproductive Cancer
• Gestational Trophoblastic Tumor
• Ovarian Epithelial Cancer
• Ovarian Germ Cell Tumor
• Sexual Dysfunction
• Uterine Sarcoma
• Vaginal Cancer
• Vulvar Cancer

Interventions

Type	Name	Description
OTHER	informational intervention	Given scripted intervention
OTHER	counseling intervention	Given standard counseling
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-06-01
• Completion: 2016-06-01
• First posted: 2014-03-26
• Last updated: 2019-11-18

Locations

1 site across 1 country: United States