Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Psychosexual Intervention in Patients With Stage I-III Gynecologic Cancer

Protocol: OSU-10077

Full Title

Psychosexual Intervention for Gynecologic and Breast Cancer Patients

Purpose

This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic cancer. Psychosexual intervention may improve sexual and psychosocial function.

Study Objective

PRIMARY OBJECTIVES:

I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a phase II randomized clinical trial (RCT).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic cancer treatments and sexuality, and provision of a survivorship care plan (SCP) created using OncoLink over 1 hour following baseline assessment and before 6 months.

ARM II (Psychological intervention): Patients participate in individual or group therapy over 1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.

After completion of study treatment, patients are followed up at 3, 6, and 9 months.

Are you eligible?

Inclusion Criteria:

Stage I-III gynecologic cancer (any site)

Current heterosexual or lesbian sexual partner

Able to speak/read English

Able to give informed consent

Exclusion Criteria:

Prior non-gynecologic cancer diagnosis

Refusal of any cancer treatment(s)

Non-ambulatory

Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit

Major mental illness (e.g, schizophrenia, major depressive disorder)

Current selective serotonin reuptake inhibitor (SSRI) use

Current/recent (prior 12 months) pregnancy

Residence > 70 miles from research site

Breast Cancer Gynecologic Cancers Cervical Cancer Endometrial Cancer Ovarian Cancer Vaginal Cancer Vulvar Cancer