Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anxiety Disorder
- Sponsor
- University of Wisconsin, Madison
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Feasibility of patient recruitment
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
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
Outcomes
Primary Outcomes
Feasibility of patient recruitment
Time Frame: Up to 9 months
To inform possible issues in recruitment for a large-scale randomized controlled trial, the ratio of enrolled subjects to total eligible potential subjects as well as the time necessary to recruit those subjects will be tracked.
Secondary Outcomes
- Resumption of sexual activity after cancer surgery(Up to 9 months)
- Satisfaction with sex life independent of specific sexual function measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global Satisfaction with Sex Life questionnaire(Up to 9 months)
- Recall of intervention(Up to 9 months)
- Retention(Up to 9 months)
- PROMIS Sexual Function Profile(Up to 9 months)
- Patient-reported anxiety measured by PROMIS Anxiety 4a short form(Up to 6 months)
- Rate of referral acceptance(Up to 9 months)