Clinical trial NCT02096783: Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
Official title: Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-26
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility of patient recruitment
timeFrame: Up to 9 months
Secondary outcomes:
measure: Resumption of sexual activity after cancer surgery
timeFrame: Up to 9 months
measure: Retention
timeFrame: Up to 9 months
measure: Satisfaction with sex life independent of specific sexual function measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global Satisfaction with Sex Life questionnaire
timeFrame: Up to 9 months
measure: PROMIS Sexual Function Profile
timeFrame: Up to 9 months
measure: Recall of intervention
timeFrame: Up to 9 months
measure: Patient-reported anxiety measured by PROMIS Anxiety 4a short form
timeFrame: Up to 6 months
measure: Rate of referral acceptance
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David Kushner
role: PRINCIPAL_INVESTIGATOR
References: