Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
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
Conditions: official terms
Anxiety Disorders - Germinoma - Gestational Trophoblastic Disease - Neoplasms, Glandular and Epithelial - Ovarian Neoplasms - Trophoblastic Neoplasms - Uterine Cervical Neoplasms - Vaginal Neoplasms - Vulvar Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Intervention
Name: informational intervention Type: Other
Name: counseling intervention Type: Other
Name: questionnaire administration Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Locations
University of Chicago
Chicago, Illinois, United States
Status: Not yet recruiting
Contact: Seiko D. Yamada - 773-834-7424 - sdyamada@babies.bsd.uchicago.edu
University of Wisconsin, Madison
Madison, Wisconsin, United States
Status: Recruiting
Contact: David M. Kushner - 800-622-8922 - cancerconnect@uwcarbone.wisc.edu
Start Date
September 2014
Completion Date
August 2016
Sponsors
University of Wisconsin, Madison
Source
University of Wisconsin, Madison
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page