Breast Cancer Clinical Trial
Official 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 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.
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