Comparison of 3 Modes of Genetic Counseling in High-Risk Public Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,273
- 试验地点
- 6
- 主要终点
- Differences in change scores among three counseling modes: Impact of Events Scale
研究概览
简要总结
Using mixed methods, investigators will conduct a multicenter partially randomized preference noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking patients assigned by (1) patients´ preference or (2) randomization to three counseling modes: (a) in-person; (b) phone; or (c) video conference. A total of 600 patients will complete counseling and 540 will complete the final survey. Baseline and post-counseling surveys will use validated measures (adapted for literacy and language) of study outcomes. All counseling sessions will be audio-taped. A sample of 90 tapes will be analyzed for counseling content and to identify 30 participants for in-depth interviews and analysis triangulating all forms of data. Genetic counselors will be interviewed in depth to elicit their perceptions of the strengths and limitations of each counseling mode.
详细描述
Specific Aims.
The specific aims of this mixed methods study are:
Aim 1. Compare the effectiveness of 3 modes of genetic counseling in a diverse sample of patients at high risk for HBOC in 3 public hospitals. Conduct a multicenter partially randomized preference noninferiority trial with high-risk patients assigned by (a) randomization to three counseling modes: in-person, phone, video conference; or (b) patients´ preference. Utilize validated measures of study outcomes adapted as needed for literacy and language. Recognizing that some potential participants may have a strong preference for one counseling mode, after explaining the study design and obtaining informed consent, participants will be asked if they have such a preference. Those who do will be offered that mode, and those who do not will be randomized. Randomization will be stratified according to hospital and personal history of breast cancer in order to ensure that there is no imbalance in important factors that may be associated with outcome.
Aim 2. Explore inductively and qualitatively variation in patients' genetic counseling experiences and understandings, genetic counselor satisfaction and perceptions, counseling session similarities and differences, and implications of organizational context across three modes of genetic counseling.
Aim 3 employs inductive, qualitative methods to explore in depth the cases of 30 patients using their pre- and post-counseling survey responses, audio tapes of their counseling session, and in-depth interviews to explore questions common to all respondents and those specific to what was learned about the individual from the other data sources. In-depth interviews will also be conducted with genetic counselors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible participants include patients who
- •visit the mammography, high risk or oncology clinics at Contra Costa County, Highland or SFGH hospitals,
- •are referred to genetic counseling services at SFGH by a community clinic through the E-Referral system or are considered to be high risk based on their breast/ovarian cancer genetics Referral Screening Tool (RST) score (≥ 2 checks)
- •speak English, Spanish, or Cantonese
- •Investigators will also include two genetic counselors who provide services at SFGH and UCSF.
排除标准
- •do not speak English, Spanish, or Cantonese;
- •are age 17 and under; and
- •don't have a family history of cancer.
结局指标
主要结局
Differences in change scores among three counseling modes: Impact of Events Scale
时间窗: One week post counseling
Will measure cancer-specific distress before and after delivery of counseling modes.
Differences in change scores among three counseling modes: Breast Cancer Knowledge Scale
时间窗: One week post counseling
Will measure knowledge of hereditary breast cancer information before and after delivery of counseling modes.
次要结局
- Differences in change scores among three counseling modes: Perceptions of Risks and Benefits of Genetic Counseling Scale(One week post counseling)
- Differences in change scores among three counseling modes: Genetic Counseling Satisfaction Scale(One week post counseling)
- Differences in change scores among three counseling modes: Perceived Stress Scale(One week post counseling)
- Differences in change scores among three counseling modes: Breast/Ovarian Cancer Risk Perception and Worry Scale(One week post counseling)
- Differences in change scores among three counseling modes: Decisional Conflict Scale(One week post counseling)