Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
Psychosexual Intervention in Patients With Stage I-III Gynecologic Cancer
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.
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?
Stage I-III gynecologic cancer (any site)
Current heterosexual or lesbian sexual partner
Able to speak/read English
Able to give informed consent
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