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

May 25, 2018 updated by: Kristen Carpenter, Ohio State University Comprehensive Cancer Center

Psychosexual Intervention for Gynecologic and Breast Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: behavioral, psychological or informational intervention
Participate in enhanced standard care
Other: behavioral, psychological or informational intervention
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.
Other: behavioral, psychological or informational intervention
Participate in enhanced standard care
Other: behavioral, psychological or informational intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kristen M. Carpenter, Ph.D, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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