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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Intervention Type OTHER

Ancillary studies

Interventions

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informational intervention

Given scripted intervention

Intervention Type OTHER

counseling intervention

Given standard counseling

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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counseling and communications studies

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No