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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Ohio State University Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kristen Carpenter, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01764802
First received: January 8, 2013
Last updated: August 7, 2015
Last verified: August 2015
  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:


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
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

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
Investigators
Principal Investigator: Kristen Carpenter, Ph.D Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

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: August 7, 2015
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:
Peritoneal Diseases
Breast Neoplasms
Carcinoma
Endometrial Neoplasms
Fallopian Tube Neoplasms
Germinoma
Gestational Trophoblastic Disease
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Sarcoma
Trophoblastic Neoplasms
Uterine Cervical Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Breast Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on August 31, 2015