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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
15
Given scripted intervention
Given standard counseling
Ancillary studies
University of Wisconsin, Madison
Madison, Wisconsin, United States
Feasibility of patient recruitment
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.
Time frame: Up to 9 months
Resumption of sexual activity after cancer surgery
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.
Time frame: Up to 9 months
Retention
The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated.
Time frame: 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
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Time frame: Up to 9 months
PROMIS Sexual Function Profile
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Time frame: Up to 9 months
Recall of intervention
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.
Time frame: Up to 9 months
Patient-reported anxiety measured by PROMIS Anxiety 4a short form
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Time frame: Up to 6 months
Rate of referral acceptance
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.
Time frame: Up to 9 months
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