Enhancing Patient-Provider Communication About Sexual Concerns in Breast Cancer: Patient Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit
研究概览
简要总结
The goal of this study is to evaluate an educational video intervention (called Starting the Conversation) aimed to enhance breast cancer patients' beliefs about and communication with respect to sexual concerns. In the current study, 128 breast cancer outpatients will be randomized to either participate in the video intervention and to receive a resource guide addressing sexual and menopausal health or to receive the resource guide alone. Patients will be asked to participate in the video and/or read through the resource guide prior to their clinic visit with their breast 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 and health-related QOL.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Receiving any treatment for breast cancer or have completed acute treatment for breast cancer < 10 years ago
- •Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
- •Willing to have clinic visit audio recorded
排除标准
- •Unable to speak English
- •Eastern Cooperative Oncology Group (ECOG) Performance score > 2 OR too ill to participate as judged by physician, self-report, or observation of the research team member
- •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.
研究组 & 干预措施
Resources Only
Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.
干预措施: Sexual and Menopausal Health Resources (Behavioral)
Resources + Video
Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.
干预措施: Starting the Conversation Video (Behavioral)
Resources + Video
Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.
干预措施: Sexual and Menopausal Health Resources (Behavioral)
Clinician Arm
Clinicians were consented in order to have their clinic visits audio recorded. No outcomes data were collected from clinician participants.
结局指标
主要结局
Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit
时间窗: 2 weeks
As coded from clinic visit audio, the number of patients who ask at least one question about sexual health.
Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
时间窗: 2 months
Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy.
Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit
时间窗: 2 weeks
As coded from clinic visit audio, the number of patients who raise the topic of sexual health during their encounter (out of encounters where a sexual health discussion occurred).
Self-Reported Outcome Expectancies for Sexual Health Communication
时间窗: 2 months
Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.
Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
时间窗: 2 weeks
Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy.
Self-Reported Outcome Expectancies for Sexual Health Communication
时间窗: 2 weeks
Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.
次要结局
- Retention Rates (Feasibility)(2 months)
- Intervention Acceptability(2 weeks)
- Self-Reported Outcome Expectancies for Communication About Menopausal Health(2 months)
- Recruitment Rates (Feasibility)(baseline)
- Sexual Function(2 months)
- Self-Reported Anxiety(2 months)
- Self-Reported Depression(2 months)
- Barriers to Communicating About Sexual Health(2 months)
- Self-Reported Outcome Expectancies for Communication About Treatment Side Effects(2 months)
- General Self-Efficacy for Communication With Provider(2 months)
- Self-Reported Quality of Life(2 months)
- Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects(2 months)
- Sexual Activity(2 months)
- Self-Reported Self-Efficacy for Communicating About About Menopausal Health(2 months)
- Retention Rates (Feasibility)(2 weeks)
- Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects(2 weeks)
- Self-Reported Self-Efficacy for Communicating About About Menopausal Health(2 weeks)
- Self-Reported Outcome Expectancies for Communication About Treatment Side Effects(2 weeks)
- Self-Reported Outcome Expectancies for Communication About Menopausal Health(2 weeks)