Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2016 by Ohio State University Comprehensive Cancer Center
Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kristen Carpenter, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01764802
First received: January 8, 2013
Last updated: May 2, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Other: behavioral, psychological or informational intervention |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Psychosexual Intervention for Gynecologic and Breast Cancer Patients |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Fallopian Tube Cancer
Ovarian Epithelial Cancer
Malignant Mesenchymal Tumor
Soft Tissue Sarcoma
Gestational Trophoblastic Tumor
Vaginal Cancer
Ovarian Germ Cell Tumor
Vulvar Cancer
Uterine Sarcoma
Ovarian Cancer
U.S. FDA Resources
Further study details as provided by Ohio State University Comprehensive Cancer Center:
Primary Outcome Measures:
- Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES) [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]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.
- Sexual responsiveness (desire, arousal, orgasm) using the Female Sexual Functioning Index (FSFI) [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]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.
- Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI) [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]95% confidence intervals will be obtained.
- Sexual distress graded using the female Sexual Distress Scale (FSDS) [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]The Likert scale will be used. 95% confidence intervals will be obtained.
- Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Emotional distress graded using the Profile of Mood States (POMS) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]The Likert scale will be used. 95% confidence intervals will be obtained.
- Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]The Likert scale will be used. 95% confidence intervals will be obtained.
- Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]The eight primary subscales are summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
- Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
- Body change stress graded according to the Impact of Treatment Scale (ITS) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: behavioral, psychological or informational intervention
Participate in enhanced standard care
|
|
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.
|
Other: behavioral, psychological or informational intervention
Participate in psychological intervention
|
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| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764802
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764802
Contacts
| Contact: Ohio State University Comprehensive Cancer Center | 1-800-293-5066 | Jamesline@osumc.edu | |
| Contact: Kristen Carpenter, Ph.D. | 614-292-6874 | Carpenter.292@osu.edu |
Locations
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Kristen Carpenter, Ph.D 614-293-9201 Carpenter.292@osu.edu | |
| Principal Investigator: Carpenter Kristen, Ph.D | |
| Sub-Investigator: Andersen Barbara, Ph.D | |
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Kristen Carpenter, Ph.D | Ohio State University Comprehensive Cancer Center |
More Information
Additional Information:
| Responsible Party: | Kristen Carpenter, Principal Investigator, Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01764802 History of Changes |
| Other Study ID Numbers: | OSU-10077 NCI-2012-01341 1R21CA149675-01A1 |
| Study First Received: | January 8, 2013 |
| Last Updated: | May 2, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University Comprehensive Cancer Center:
|
Psychosexual Intervention Cancer Gynecologic Cancer Breast Cancer |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Breast Neoplasms Carcinoma Sarcoma Uterine Cervical Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Germinoma Vulvar Neoplasms Vaginal Neoplasms Gestational Trophoblastic Disease Trophoblastic Neoplasms |
Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases |
ClinicalTrials.gov processed this record on September 28, 2016