Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
- Conditions
- Cervical CancerEndometrial CancerGestational Trophoblastic TumorOvarian Epithelial CancerOvarian Germ Cell TumorSexual DysfunctionVulvar CancerAnxiety DisorderVaginal CancerFemale Reproductive Cancer
- Interventions
- Other: informational interventionOther: questionnaire administrationOther: counseling intervention
- Registration Number
- NCT02096783
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
- 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
- Previous treatment of any cancer excluding skin cancer
- Patients with a suspected benign gynecologic process
- Patients who are prisoners or incarcerated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (standard counseling) questionnaire administration Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit. Arm III (standard counseling, scripted intervention) counseling intervention 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 II (standard counseling, scripted intervention) counseling intervention Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit. Arm II (standard counseling, scripted intervention) informational intervention Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit. Arm I (standard counseling) counseling intervention Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit. Arm II (standard counseling, scripted intervention) questionnaire administration 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 (standard counseling, scripted intervention) informational intervention 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 III (standard counseling, scripted intervention) questionnaire administration 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 (standard counseling, scripted intervention) questionnaire administration Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit. Arm IV (standard counseling, scripted intervention) counseling intervention Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit. Arm IV (standard counseling, scripted intervention) informational intervention Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
- Primary Outcome Measures
Name Time Method Feasibility of patient recruitment 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 Outcome Measures
Name Time Method Resumption of sexual activity after cancer surgery Up to 9 months Resumption of sexual activity after cancer surgery will be measured using items adapted from a previous national, multi-site study of sexual outcomes following an acute myocardial infarction.
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 Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Recall of intervention Up to 9 months Subjects will be queried to learn whether they recall receiving physician counseling about sexual health outcomes after surgery with follow up questions regarding whether or not the patient has spoken with other healthcare providers about sexual concerns.
Retention Up to 9 months The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated.
PROMIS Sexual Function Profile Up to 9 months Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Patient-reported anxiety measured by PROMIS Anxiety 4a short form Up to 6 months Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Rate of referral acceptance Up to 9 months The rate of acceptance of sexual health clinic referrals as well as rates of utilization of these referrals will be tracked using medical record abstraction.
Trial Locations
- Locations (1)
University of Wisconsin, Madison
🇺🇸Madison, Wisconsin, United States