Breast Cancer Clinical Trial
Official title:
Psychosexual Intervention for Gynecologic and Breast Cancer Patients
| Verified date | May 2018 |
| Source | Ohio State University Comprehensive Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | June 1, 2017 |
| Est. primary completion date | June 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 21 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI) | 95% confidence intervals will be obtained. | Up to 2 months | |
| Primary | 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 | |
| Primary | Sexual pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version | Up to 9 months | ||
| Secondary | Emotional distress graded using the Profile of Mood States (POMS) | The Likert scale will be used. 95% confidence intervals will be obtained. | Up to 9 months | |
| Secondary | Depressive symptoms graded using the Center for Epidemiologic Studies Depression Scale (CES-D) | The Likert scale will be used. 95% confidence intervals will be obtained. | Up to 9 months | |
| Secondary | Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12) | 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 | |
| Secondary | Cancer-related stress graded according to the Impact of Events Scale-Revised (IES-R) | Up to 9 months | ||
| Secondary | Body change stress graded according to the Impact of Treatment Scale (ITS) | Up to 9 months |
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