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Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer

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ClinicalTrials.gov Identifier: NCT01764802
Recruitment Status : Recruiting
First Posted : January 10, 2013
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kristen Carpenter, Ohio State University Comprehensive Cancer Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychosexual Intervention for Gynecologic and Breast Cancer Patients
Study Start Date : October 2010
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version [ Time Frame: Up to 9 months ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R) [ Time Frame: Up to 9 months ]
  5. Body change stress graded according to the Impact of Treatment Scale (ITS) [ Time Frame: Up to 9 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764802


Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Nichole Storey 614-685-8754 nichole.storey@osumc.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: Nichole Storey    614-685-8754    nichole.storey@osumc.edu   
Principal Investigator: Carpenter Kristen, Ph.D         
Sub-Investigator: Andersen Barbara, Ph.D         
Sub-Investigator: Fowler Jeffrey, MD         
Sub-Investigator: Salani Ritu, MD         
Sub-Investigator: Lustberg Maryum, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kristen M. Carpenter, Ph.D Ohio State University Comprehensive Cancer Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Jamesline  This link exits the ClinicalTrials.gov site

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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1R21CA149675-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Keywords provided by Kristen Carpenter, Ohio State University Comprehensive Cancer Center:
Psychosexual Intervention
Cancer
Gynecologic Cancer
Breast Cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Carcinoma
Breast Neoplasms
Neoplasms
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
Trophoblastic Neoplasms
 Gestational Trophoblastic Disease
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
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