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

University of Wisconsin (UW)

Status: Completed

Conditions: Endometrial Cancer; Vulvar Cancer; Uterine Sarcoma; Gestational Trophoblastic Tumor; Vaginal Cancer; Female Reproductive Cancer; Anxiety Disorder; Sexual Dysfunction; Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Cervical Cancer

Treatments: Other: counseling intervention; Other: informational intervention; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02096783

UW13080 (Other Identifier)

NCI-2014-00471 (Registry Identifier)

P30CA014520 (U.S. NIH Grant/Contract)

A532820 (Other Identifier)

2014-0122 (Other Identifier)

SMPH/OBSTET & GYNECOL/OBSTET (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 4 patient groups

Arm I (standard counseling)

Active Comparator group

Description:

Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.

Treatment:

Other: questionnaire administration

Other: counseling intervention

Arm II (standard counseling, scripted intervention)

Experimental group

Description:

Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.

Treatment:

Other: informational intervention

Other: questionnaire administration

Other: counseling intervention

Arm III (standard counseling, scripted intervention)

Experimental group

Description:

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.

Treatment:

Other: informational intervention

Other: questionnaire administration

Other: counseling intervention

Arm IV (standard counseling, scripted intervention)

Experimental group

Description:

Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.

Treatment:

Other: informational intervention

Other: questionnaire administration

Other: counseling intervention