Enhancing Clinical Communication About Sexual Health for Women With Gynecologic Cancer: Adaptation of a Multimedia Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Feasibility - Enrollment
研究概览
简要总结
The central goal of this randomized, controlled pilot study is to examine the feasibility, acceptability, and preliminary effects of an educational intervention (called "Starting the Conversation"; STC) on patient communication about sexual health in gynecologic cancer and other patient health outcomes. Approximately 30 women with a diagnosis of gynecologic cancer will be randomized to either participate in either the Starting the Conversation (STC) condition, consisting of an educational video, workbook, and list of resources on sexual and menopausal health, or to a control condition offering the resource guide only. Patients will be asked to review intervention materials prior to their next clinic visit with their gynecologic cancer provider. The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being.
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
- •Diagnosis of any stage (I-IV) gynecologic cancer (uterine, ovarian, cervical, vaginal/vulvar, fallopian tube, peritoneal)
- •Receiving any treatment for gynecologic cancer or have completed acute treatment < 10 years ago
- •Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
排除标准
- •Not able to speak English
- •Eastern Cooperative Oncology Group (ECOG) Performance status score > 2
- •Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.
结局指标
主要结局
Feasibility - Enrollment
时间窗: Baseline
Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation
Feasibility - Retention
时间窗: 2 months
Number of enrolled participants that complete the final study survey.
Feasibility - Intervention Completion
时间窗: 2 weeks
Number of participants randomized to receive the Starting the Conversation intervention who report having engaged at least somewhat with the video and/or accompanying workbook.
Acceptability
时间窗: 2 weeks
The number of participants randomized to receive the Starting the Conversation intervention who endorse at least 6 of 8 core components of the Starting the Conversation Intervention (defined as satisfaction with the intervention, informativeness of the intervention, helpfulness of the intervention, relevance of the intervention, ease of participation, approval of the intervention format, likelihood of recommending the intervention to others, and perceived importance of the intervention for people with gynecologic cancer).
次要结局
- Self-Efficacy - Post-Intervention(2 weeks)
- Self-Efficacy - 2-Month Follow Up(2 months)
- Clinical Communication - Discussion of Sexual Health(2 weeks)
- Clinical Communication - Raising Topic of Sexual Health(2 weeks)
- Clinical Communication - Asking a Question About Sexual Health(2 weeks)
- Change in Sexual Function(baseline to 2 months)
- Sexual Activity(2 months)
- Psychological Distress - Depression(2 months)
- Psychological Distress - Anxiety(2 months)