African American Cancer Clinical Trial Decisions: Testing Tailored Messages
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Demonstrate the efficacy of the tailored health message intervention to increase patient activation.
研究概览
简要总结
The purpose of this study is to determine if the use of tailored health messages and/or involving physicians are effective in increasing African American (AA) patient activation in a clinical trial consultation. The proposal will use a composite score for patient activation derived from the Street Patient Activation Coding system. This will help to determine the effectiveness of our intervention on patient activation and patient centered clinical trial decision.
详细描述
A randomized clinical trial (using a 2x2 factorial design) to inform our knowledge of the efficacy of a tailored health message intervention, using different depths of tailoring and involving physicians, on AA cancer patients' active communication in CT consultations as measured by the Street Patient Activation measure. In this study 357 AA cancer patients will be randomized into one of four experimental groups Group 1 - messages tailored on Electronic Medical Record (EMR) data. Group 2 - messages tailored on EMR + physician involvement. Group 3 - messages tailored on EMR + survey. Group 4 - Messages tailored on EMR + survey + physician involvement. We will also measure patient: a) trust in their physician, b) trust in medical research, c) preferences that include information and decision involvement, d) communication self-efficacy, e) patient-family member communication congruence, f) consultation satisfaction and g) decision outcomes that include decisional conflict, decision satisfaction and decision regret.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older
- •Have a cancer diagnosis
- •Self identify as African American
- •Therapeutic Phase I, II or III clinical trial at Massey Cancer Center (regardless of whether or not they join the therapeutic trial)
- •Be able to provide informed consent
- •We will also recruit one family member/caregiver (N = 357) of each participating patient
- •Consented patients will not be excluded from this study if their family member declines to participate by completing the Cancer Communication Assessment Tool for Families (CCAT-F).
- •Exclusions Criteria:
排除标准
- 未提供
结局指标
主要结局
Demonstrate the efficacy of the tailored health message intervention to increase patient activation.
时间窗: 40 days
Randomized clinical trial (using a 2x2 factorial design) to inform our knowledge of the efficacy of a tailored health message intervention, using different depths of tailoring and involving physicians, on AA cancer patients' active communication in CT consultations. In this study AA cancer patients will be randomized into one of four experimental groups. Scientifically determine the effectiveness of our intervention by using a composite score for patient activation derived from the Street Patient Activation Coding system.
次要结局
未报告次要终点