- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764802
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
Psychosexual Intervention for Gynecologic and Breast Cancer Patients
Study Overview
Status
Conditions
- Breast Cancer
- Ovarian Sarcoma
- Stage III Uterine Sarcoma
- Ovarian Stromal Cancer
- Stage I Uterine Sarcoma
- Stage II Uterine Sarcoma
- Stage IIA Fallopian Tube Cancer
- Stage IIB Fallopian Tube Cancer
- Stage IIC Fallopian Tube Cancer
- Stage IIIA Fallopian Tube Cancer
- Stage IIIB Fallopian Tube Cancer
- Stage IIIC Fallopian Tube Cancer
- Stage III Vulvar Cancer
- Stage I Vaginal Cancer
- Stage I Vulvar Cancer
- Stage IA Cervical Cancer
- Stage IB Cervical Cancer
- Stage II Vaginal Cancer
- Stage II Vulvar Cancer
- Stage IIA Cervical Cancer
- Stage IIB Cervical Cancer
- Stage III Vaginal Cancer
- Stage IIA Ovarian Germ Cell Tumor
- Stage IIB Ovarian Germ Cell Tumor
- Stage IIC Ovarian Germ Cell Tumor
- Stage IIIA Ovarian Germ Cell Tumor
- Stage IIIB Ovarian Germ Cell Tumor
- Stage IIIC Ovarian Germ Cell Tumor
- Stage IIIA Ovarian Epithelial Cancer
- Stage IIIB Ovarian Epithelial Cancer
- Stage IIIC Ovarian Epithelial Cancer
- Stage IIA Ovarian Epithelial Cancer
- Stage IIB Ovarian Epithelial Cancer
- Stage IIC Ovarian Epithelial Cancer
- Stage IIIA Cervical Cancer
- Stage IIIB Cervical Cancer
- Stage IIIA Primary Peritoneal Cavity Cancer
- Stage IIIB Primary Peritoneal Cavity Cancer
- Stage IIIC Primary Peritoneal Cavity Cancer
- Stage IIA Primary Peritoneal Cavity Cancer
- Stage IIB Primary Peritoneal Cavity Cancer
- Stage IIC Primary Peritoneal Cavity Cancer
- Stage II Gestational Trophoblastic Tumor
- Stage III Gestational Trophoblastic Tumor
- Stage IA Endometrial Carcinoma
- Stage IB Endometrial Carcinoma
- Stage II Endometrial Carcinoma
- Stage IIIA Endometrial Carcinoma
- Stage IIIB Endometrial Carcinoma
- Stage IIIC Endometrial Carcinoma
- Stage IA Fallopian Tube Cancer
- Stage IA Ovarian Germ Cell Tumor
- Stage IB Fallopian Tube Cancer
- Stage IB Ovarian Germ Cell Tumor
- Stage IC Fallopian Tube Cancer
- Stage IC Ovarian Germ Cell Tumor
- Stage IA Ovarian Epithelial Cancer
- Stage IB Ovarian Epithelial Cancer
- Stage IC Ovarian Epithelial Cancer
- Stage IA Primary Peritoneal Cavity Cancer
- Stage IB Primary Peritoneal Cavity Cancer
- Stage IC Primary Peritoneal Cavity Cancer
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm I (enhanced standard care)
Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.
|
Participate in enhanced standard care
Participate in psychological intervention
|
Experimental: Arm II (psychological intervention)
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.
|
Participate in enhanced standard care
Participate in psychological intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES)
Time Frame: Up to 2 months
|
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.
|
Up to 2 months
|
Sexual responsiveness (desire, arousal, orgasm) using the Female Sexual Functioning Index (FSFI)
Time Frame: Up to 4 weeks
|
Principal components analysis yields six subscales: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Items are rated using the Likert scales.
95% confidence intervals will be obtained.
|
Up to 4 weeks
|
Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)
Time Frame: Up to 2 months
|
95% confidence intervals will be obtained.
|
Up to 2 months
|
Sexual distress graded using the female Sexual Distress Scale (FSDS)
Time Frame: Up to 4 weeks
|
The Likert scale will be used.
95% confidence intervals will be obtained.
|
Up to 4 weeks
|
Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version
Time Frame: Up to 9 months
|
Up to 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotional distress graded using the Profile of Mood States (POMS)
Time Frame: Up to 9 months
|
The Likert scale will be used.
95% confidence intervals will be obtained.
|
Up to 9 months
|
Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Up to 9 months
|
The Likert scale will be used.
95% confidence intervals will be obtained.
|
Up to 9 months
|
Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12)
Time Frame: Up to 9 months
|
The eight primary subscales are summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
|
Up to 9 months
|
Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R)
Time Frame: Up to 9 months
|
Up to 9 months
|
|
Body change stress graded according to the Impact of Treatment Scale (ITS)
Time Frame: Up to 9 months
|
Up to 9 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kristen M. Carpenter, Ph.D, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Breast Diseases
- Pregnancy Complications
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Vaginal Diseases
- Vulvar Diseases
- Pregnancy Complications, Neoplastic
- Sarcoma
- Uterine Cervical Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Breast Neoplasms
- Carcinoma
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Endometrial Neoplasms
- Carcinoma, Ovarian Epithelial
- Vulvar Neoplasms
- Trophoblastic Neoplasms
- Vaginal Neoplasms
- Gestational Trophoblastic Disease
- Germinoma
Other Study ID Numbers
- OSU-10077
- NCI-2012-01341 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 1R21CA149675-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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