Overview

This trial has been completed.

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
Treatments informational intervention, counseling intervention, questionnaire administration
Sponsor University of Wisconsin, Madison
Collaborator National Cancer Institute (NCI)
Start date September 2014
End date June 2015
Trial size 15 participants
Trial identifier NCT02096783, NCI-2014-00471, P30CA014520, UW13080

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Active Comparator)
Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.
counseling intervention counseling and communications studies
Given standard counseling
questionnaire administration
Ancillary studies
(Experimental)
Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.
informational intervention
Given scripted intervention
counseling intervention counseling and communications studies
Given standard counseling
questionnaire administration
Ancillary studies
(Experimental)
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.
informational intervention
Given scripted intervention
counseling intervention counseling and communications studies
Given standard counseling
questionnaire administration
Ancillary studies
(Experimental)
Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
informational intervention
Given scripted intervention
counseling intervention counseling and communications studies
Given standard counseling
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
Feasibility of patient recruitment
time frame: Up to 9 months

Secondary Outcomes

Measure
Resumption of sexual activity after cancer surgery
time frame: Up to 9 months
Retention
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
time frame: Up to 9 months
PROMIS Sexual Function Profile
time frame: Up to 9 months
Recall of intervention
time frame: Up to 9 months
Patient-reported anxiety measured by PROMIS Anxiety 4a short form
time frame: Up to 6 months
Rate of referral acceptance
time frame: Up to 9 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer
Principal investigator David Kushner
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.