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


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


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)


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