Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast 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 or breast cancer. Psychosexual intervention may improve sexual and psychosocial function.

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 or breast 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.

Inclusion Criteria:

• Stage I-III gynecologic (any site) or breast cancer
• Able to speak/read English
• Able to give informed consent

Exclusion Criteria:

• Prior non-gynecologic/breast 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/recent (prior 12 months) pregnancy
• Residence > 70 miles from research site