Trials / Completed
CompletedNCT01764802
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
Psychosexual Intervention for Gynecologic and Breast Cancer Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | behavioral, psychological or informational intervention | Participate in enhanced standard care |
| OTHER | behavioral, psychological or informational intervention | Participate in psychological intervention |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2013-01-10
- Last updated
- 2018-05-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01764802. Inclusion in this directory is not an endorsement.