Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer

The Ohio State University

Status and phase: Completed; Phase 2

Conditions: Stage IB Cervical Cancer; Stage IIB Primary Peritoneal Cavity Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IB Ovarian Germ Cell Tumor; Stage IIIC Ovarian Germ Cell Tumor; Stage IB Primary Peritoneal Cavity Cancer; Stage III Uterine Sarcoma; Stage IIC Ovarian Epithelial Cancer; Stage IIA Cervical Cancer; Stage II Vaginal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIA Ovarian Germ Cell Tumor; Stage IC Primary Peritoneal Cavity Cancer; Breast Cancer; Stage IA Ovarian Germ Cell Tumor; Stage IIC Fallopian Tube Cancer; Stage IIA Ovarian Germ Cell Tumor; Stage I Vaginal Cancer; Stage IB Ovarian Epithelial Cancer; Stage IA Primary Peritoneal Cavity Cancer; Ovarian Sarcoma; Stage IIIA Cervical Cancer; Stage IIIC Endometrial Carcinoma; Stage II Vulvar Cancer; Stage IIA Ovarian Epithelial Cancer; Stage IIB Ovarian Germ Cell Tumor; Stage IIIA Fallopian Tube Cancer; Stage IB Fallopian Tube Cancer; Stage I Uterine Sarcoma; Stage IIIB Endometrial Carcinoma; Stage IA Ovarian Epithelial Cancer; Stage II Endometrial Carcinoma; Stage IC Ovarian Germ Cell Tumor; Stage IIB Ovarian Epithelial Cancer; Stage IIB Fallopian Tube Cancer; Stage IC Fallopian Tube Cancer; Stage III Vulvar Cancer; Stage III Gestational Trophoblastic Tumor; Stage IIIC Ovarian Epithelial Cancer; Stage IIIB Primary Peritoneal Cavity Cancer; Stage IIB Cervical Cancer; Stage II Gestational Trophoblastic Tumor; Stage IIIC Primary Peritoneal Cavity Cancer; Stage IC Ovarian Epithelial Cancer; Stage IA Endometrial Carcinoma; Stage I Vulvar Cancer; Stage II Uterine Sarcoma; Stage IA Fallopian Tube Cancer; Stage IB Endometrial Carcinoma; Stage IIIB Cervical Cancer; Stage IIIA Primary Peritoneal Cavity Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIA Primary Peritoneal Cavity Cancer; Stage IIA Fallopian Tube Cancer; Stage IIIA Endometrial Carcinoma; Stage IIC Ovarian Germ Cell Tumor; Ovarian Stromal Cancer; Stage III Vaginal Cancer; Stage IIC Primary Peritoneal Cavity Cancer; Stage IA Cervical Cancer; Stage IIIB Ovarian Germ Cell Tumor

Treatments: Other: behavioral, psychological or informational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01764802

1R21CA149675-01A1 (U.S. NIH Grant/Contract)

NCI-2012-01341 (Registry Identifier)

OSU-10077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm I (enhanced standard care)

Active Comparator group

Description:

Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.

Treatment:

Other: behavioral, psychological or informational intervention

Other: behavioral, psychological or informational intervention

Arm II (psychological intervention)

Experimental group

Description:

Patients participate in individual or group therapy over 1.5 hours weekly for 6 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.

Treatment:

Other: behavioral, psychological or informational intervention

Other: behavioral, psychological or informational intervention