Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer

Cervical Cancer Clinical Trial

Official title:

Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096783
• Other study ID #: UW13080
• Secondary ID: NCI-2014-00471UW
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Carcinoma, Ovarian Epithelial
• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Female Reproductive Cancer
• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Ovarian Epithelial Cancer
• Ovarian Germ Cell Tumor
• Sexual Dysfunction
• Trophoblastic Neoplasms
• Uterine Sarcoma
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Other:
• informational intervention
Given scripted intervention
• counseling intervention
Given standard counseling
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	University of Wisconsin, Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	Retention	The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	PROMIS Sexual Function Profile	Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	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.	Up to 6 months
Secondary	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.	Up to 9 months

External Links

•   University of Wisconsin Carbone Cancer Center