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

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Ovarian Epithelial Cancer; Sexual Dysfunction; Uterine Sarcoma; Vulvar Cancer; Endometrial Cancer; Gestational Trophoblastic Tumor; Vaginal Cancer; Ovarian Germ Cell Tumor; Anxiety Disorder; Female Reproductive Cancer
• Intervention / Treatment: Other: questionnaire administration; Other: counseling intervention; Other: informational intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin, Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (standard counseling); Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.	Other: questionnaire administration; Ancillary studies; Other: counseling intervention; Given standard counseling; Other Names: counseling and communications studies
Experimental: Arm II (standard counseling, scripted intervention); Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.	Other: questionnaire administration; Ancillary studies; Other: counseling intervention; Given standard counseling; Other Names: counseling and communications studies; Other: informational intervention; Given scripted intervention
Experimental: Arm III (standard counseling, scripted intervention); 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.	Other: questionnaire administration; Ancillary studies; Other: counseling intervention; Given standard counseling; Other Names: counseling and communications studies; Other: informational intervention; Given scripted intervention
Experimental: Arm IV (standard counseling, scripted intervention); Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.	Other: questionnaire administration; Ancillary studies; Other: counseling intervention; Given standard counseling; Other Names: counseling and communications studies; Other: informational intervention; Given scripted intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Retention	The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated.	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.	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.	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.	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.	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.	Up to 9 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: David Kushner, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Neoplasms, Germ Cell and Embryonal; Pregnancy Complications; Vaginal Diseases; Vulvar Diseases; Ovarian Neoplasms; Pregnancy Complications, Neoplastic; Anxiety Disorders; Endometrial Neoplasms; Carcinoma, Ovarian Epithelial; Vulvar Neoplasms; Trophoblastic Neoplasms; Vaginal Neoplasms
• Other Study ID Numbers: UW13080 (Other Identifier: University of Wisconsin Carbone Cancer Center); P30CA014520 (U.S. NIH Grant/Contract); A532820 (Other Identifier: UW Madison); SMPH/OBSTET & GYNECOL/OBSTET (Other Identifier: UW Madison); NCI-2014-00471 (Registry Identifier: NCI Trial ID); 2014-0122 (Other Identifier: Institutional Review Board)