Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
Condition: Ovarian Sarcoma; Ovarian Stromal Cancer; Stage I Uterine Sarcoma; Stage I Vaginal Cancer; Stage I Vulvar Cancer; Stage IA Cervical Cancer; Stage IA Endometrial Carcinoma; Stage IA Fallopian Tube Cancer; Stage IA Ovarian Epithelial Cancer; Stage IA Ovarian Germ Cell Tumor; Stage IA Primary Peritoneal Cavity Cancer; Stage IB Cervical Cancer; Stage IB Endometrial Carcinoma; Stage IB Fallopian Tube Cancer; Stage IB Ovarian Epithelial Cancer; Stage IB Ovarian Germ Cell Tumor; Stage IB Primary Peritoneal Cavity Cancer; Stage IC Fallopian Tube Cancer; Stage IC Ovarian Epithelial Cancer; Stage IC Ovarian Germ Cell Tumor; Stage IC Primary Peritoneal Cavity Cancer; Stage II Endometrial Carcinoma; Stage II Gestational Trophoblastic Tumor; Stage II Uterine Sarcoma; Stage II Vaginal Cancer; Stage II Vulvar Cancer; Stage IIA Cervical Cancer; Stage IIA Fallopian Tube Cancer; Stage IIA Ovarian Epithelial Cancer; Stage IIA Ovarian Germ Cell Tumor; Stage IIA Primary Peritoneal Cavity Cancer; Stage IIB Cervical Cancer; Stage IIB Fallopian Tube Cancer; Stage IIB Ovarian Epithelial Cancer; Stage IIB Ovarian Germ Cell Tumor; Stage IIB Primary Peritoneal Cavity Cancer; Stage IIC Fallopian Tube Cancer; Stage IIC Ovarian Epithelial Cancer; Stage IIC Ovarian Germ Cell Tumor; Stage IIC Primary Peritoneal Cavity Cancer; Stage III Gestational Trophoblastic Tumor; Stage III Uterine Sarcoma; Stage III Vaginal Cancer; Stage III Vulvar Cancer; Stage IIIA Cervical Cancer; Stage IIIA Endometrial Carcinoma; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Ovarian Germ Cell Tumor; Stage IIIA Primary Peritoneal Cavity Cancer; Stage IIIB Cervical Cancer; Stage IIIB Endometrial Carcinoma; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIB Ovarian Germ Cell Tumor; Stage IIIB Primary Peritoneal Cavity Cancer; Stage IIIC Endometrial Carcinoma; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Ovarian Germ Cell Tumor; Stage IIIC Primary Peritoneal Cavity Cancer; Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms; Sarcoma; Uterine Cervical Neoplasms; Neoplasms, Germ Cell and Embryonal; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Endometrial Neoplasms; Peritoneal Neoplasms; Germinoma; Ovarian Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Trophoblastic Neoplasms; Gestational Trophoblastic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): behavioral, psychological or informational intervention; behavioral, psychological or informational intervention
Intervention type(s): Other; Other
Intervention description(s): Participate in enhanced standard care; Participate in psychological intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Psychosexual Intervention; Cancer; Gynecologic Cancer; Breast Cancer