Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
Psychosexual Intervention for Gynecologic and Breast Cancer Patients
3 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 8, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMay 30, 2018
May 1, 2018
6.7 years
January 8, 2013
May 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES)
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)
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)
95% confidence intervals will be obtained.
Up to 2 months
Sexual distress graded using the female Sexual Distress Scale (FSDS)
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
Up to 9 months
Secondary Outcomes (5)
Emotional distress graded using the Profile of Mood States (POMS)
Up to 9 months
Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D)
Up to 9 months
Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12)
Up to 9 months
Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R)
Up to 9 months
Body change stress graded according to the Impact of Treatment Scale (ITS)
Up to 9 months
Study Arms (2)
Arm I (enhanced standard care)
ACTIVE COMPARATORPatients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.
Arm II (psychological intervention)
EXPERIMENTALPatients 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.
Interventions
Participate in enhanced standard care
Eligibility Criteria
You may qualify if:
- Stage I-III gynecologic (any site) or breast cancer
- Able to speak/read English
- Able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Related Publications (1)
Black LL, Conroy K, Lustberg M, Salani R, Andersen BL, Carpenter KM. Association of sexual pain and psychological factors among gynecologic and breast cancer patients: application of components of the fear-avoidance model of chronic pain. J Behav Med. 2025 Jun;48(3):536-543. doi: 10.1007/s10865-025-00560-3. Epub 2025 Mar 13.
PMID: 40082377DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristen M. Carpenter, Ph.D
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 8, 2013
First Posted
January 10, 2013
Study Start
October 1, 2010
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
May 30, 2018
Record last verified: 2018-05