Psychosexual Intervention for Gynecologic and Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage I-III gynecologic (any site) or breast cancer
- •Able to speak/read English
- •Able to give informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: behavioral, psychological or informational intervention (Other)
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.
干预措施: behavioral, psychological or informational intervention (Other)
结局指标
主要结局
Sexual satisfaction graded using the global evaluation from the Derogatis Sexual Function Inventory (DSFI)
时间窗: Up to 2 months
95% confidence intervals will be obtained.
Sexual distress graded using the female Sexual Distress Scale (FSDS)
时间窗: Up to 4 weeks
The Likert scale will be used. 95% confidence intervals will be obtained.
Sexual behavior/repertoire (kissing, intercourse, etc.) graded using the Sexual Experiences Scale (SES)
时间窗: 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)
时间窗: 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 pain graded using the International Pelvic Pain Society Pelvic Pain Assessment, patient/physician version
时间窗: Up to 9 months
次要结局
- Health-related quality of life graded according to the RAND Medical Outcomes Study, Short-form 12 (SF-12)(Up to 9 months)
- 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)
- 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)
研究者
Kristen Carpenter
Principal Investigator
Ohio State University Comprehensive Cancer Center