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

November 14, 2019 updated by: University of Wisconsin, Madison

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

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 9 months
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
Time Frame: Up to 9 months
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
Time Frame: Up to 9 months
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
Time Frame: Up to 9 months
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
Time Frame: Up to 9 months
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
Time Frame: Up to 9 months
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
Time Frame: Up to 6 months
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
Time Frame: Up to 9 months
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: David Kushner, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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