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Psychosexual Intervention for Gynecologic Cancer Patients


Phase 2
21 Years
80 Years
Open (Enrolling)
Female
Leydig Cell Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer, Stage I Gestational Trophoblastic Tumor, 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

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Trial Information

Psychosexual Intervention for Gynecologic Cancer Patients


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 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 cancer (any site)

- Current heterosexual or lesbian sexual partner

- Able to speak/read English

- Able to give informed consent

Exclusion Criteria:

- Prior non-gynecologic 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 selective serotonin reuptake inhibitor (SSRI) use

- Current/recent (prior 12 months) pregnancy

- Residence > 70 miles from research site

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES)

Outcome Description:

Multilevel modeling will be used to model time effects compared to repeated-measures analysis of variance (ANOVA) because it allows not only fitting different patterns of average change (i.e., linear, quadratic), but also estimates individual variability in the rate of change. Both linear and quadratic change models will be tested and an optimal model will be determined. 95% confidence intervals will be obtained.

Outcome Time Frame:

Up to 2 months

Safety Issue:

No

Principal Investigator

Barbara Andersen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

OSU-10077

NCT ID:

NCT01764802

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Leydig Cell Tumor
  • Ovarian Sarcoma
  • Ovarian Stromal Cancer
  • Stage I Gestational Trophoblastic Tumor
  • 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
  • Psychosexual Intervention
  • Cancer
  • Gynecologic Cancer Patients
  • Carcinoma
  • Uterine Cervical Neoplasms
  • Leydig Cell Tumor
  • Trophoblastic Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Adenoma
  • Germinoma
  • Ovarian Neoplasms
  • Endometrial Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Gestational Trophoblastic Neoplasms
  • Sarcoma

Name

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240