A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 7
- 主要终点
- Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).
研究概览
简要总结
There is a high prevalence of sexual and body image problems among women treated for gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly personal nature of these problems, women are often reluctant to speak to their doctors about these concerns and have few resources for support and information. The research team will conduct a prospective randomized controlled trail (RCT) to test the benefits of "GyneGals," a 12-week online (i.e. Internet-based) support group intervention for women who are sexually distressed due to gynecologic cancer and its treatment.
The primary aim of this study is to determine whether a professionally-facilitated, information-rich, online support group is beneficial for women who are sexually distressed due to gynecologic cancer and the side effects of treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Received surgical, radiation or chemotherapy treatments for any gynecologic cancer
- •Not receiving active treatment
- •Currently disease-free for a minimum of 3 months
- •No more than 5 years post-diagnosis
- •Distressed due to psychosexual concerns related to cancer
- •Willing to discuss psychosexual concerns
- •18 years or older
- •Has access to a computer and the Internet
- •Speaks, reads, and writes in English
- •Provides informed consent
排除标准
- •Acutely suicidal (i.e., actively suicidal within the previous 3 months)
- •Has a major psychiatric illness
研究组 & 干预措施
Immediate Treatment Condition
Receives the 12-week GyneGals Support Group within a month of completing the baseline assessment.
干预措施: GyneGals Support Group (Behavioral)
Waitlist Control Condition
Waitlist control group receives the 12-week GyneGals Support Group only after its involvement in the study has ended, as a courtesy.
结局指标
主要结局
Psychosexual distress, as measured by the Revised Female Sexual Distress Scale (FSDS-R).
时间窗: 9 months
13-item self-report scale that measures sexually-related distress in women.
次要结局
- Body image, as measured by the Sexual Adjustment and Body Image Scale - Gynecologic Cancer (SABIS-G).(9 months (at months 1, 5, and 9))
- Depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS).(9 months (at months 1, 5, and 9))
- Relationship satisfaction, as measured by the Relationship Assessment Scale (RAS).(9 months (at months 1, 5, and 9))
- Perceived social support, as measured by MOS Social Support Survey (MOS-SS).(9 months (at months 1, 5, and 9))
- Sexual function, as measured by the Sexual Function Questionnaire (SFQ).(9 months (at months 1, 5, and 9))