Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
Study Details
Study Description
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.
Detailed Description
PRIMARY OBJECTIVES:
- 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
Arms and Interventions
| 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
Primary Outcome Measures
- Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES) [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.
- Sexual responsiveness (desire, arousal, orgasm) using the Female Sexual Functioning Index (FSFI) [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.
- Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI) [Up to 2 months]
95% confidence intervals will be obtained.
- Sexual distress graded using the female Sexual Distress Scale (FSDS) [Up to 4 weeks]
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 [Up to 9 months]
Secondary Outcome Measures
- Emotional distress graded using the Profile of Mood States (POMS) [Up to 9 months]
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) [Up to 9 months]
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) [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).
- 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]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OSU-10077
- NCI-2012-01341
- 1R21CA149675-01A1