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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02096783
Other study ID # UW13080
Secondary ID NCI-2014-00471UW
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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 patientā€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

Study Design


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
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