Clinical trial NCT01764802: Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
Official title: Psychosexual Intervention for Gynecologic and Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Keywords: Psychosexual Intervention
Cancer
Gynecologic Cancer
Breast Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-01-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES)
timeFrame: Up to 2 months
measure: Sexual responsiveness (desire, arousal, orgasm) using the Female Sexual Functioning Index (FSFI)
timeFrame: Up to 4 weeks
measure: Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)
timeFrame: Up to 2 months
measure: Sexual distress graded using the female Sexual Distress Scale (FSDS)
timeFrame: Up to 4 weeks
measure: Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version
timeFrame: Up to 9 months
Secondary outcomes:
measure: Emotional distress graded using the Profile of Mood States (POMS)
timeFrame: Up to 9 months
measure: Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Up to 9 months
measure: Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12)
timeFrame: Up to 9 months
measure: Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R)
timeFrame: Up to 9 months
measure: Body change stress graded according to the Impact of Treatment Scale (ITS)
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Kristen M. Carpenter, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: