Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 627
- 试验地点
- 58
- 主要终点
- Patient Power: Self-efficacy in Patient Physician Interactions
研究概览
简要总结
This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.
详细描述
The primary and secondary objectives of the study:
PRIMARY OBJECTIVES:
I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients.
II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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
- •Newly diagnosed with stage 0-III breast cancer
- •Eligible patients must be planning breast surgery as a component of their definitive treatment
- •Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
- •Patients with hearing impairment requiring the use of an interpreter are not eligible for this study
- •Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
- •CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer
- •INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study
- •INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation
排除标准
- 未提供
研究组 & 干预措施
Arm I (surgical consultation)
Prior to institutional crossover, participants receive care as per usual care.
干预措施: Usual Care (Other)
Arm II (web-based breast cancer surgery decision aid)
Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
干预措施: Usual Care (Other)
Arm II (web-based breast cancer surgery decision aid)
Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
干预措施: Web-based decision aid (Other)
结局指标
主要结局
Patient Power: Self-efficacy in Patient Physician Interactions
时间窗: 3 weeks
Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
Patient Power: Active Patient Participation
时间窗: 1 day
Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by the study team and represents a total count of patients' communicative behaviors (i.e., count of patient asking questions, count of patient assertive responses and count of patient expressions of concern) ranging from 0-114, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).
次要结局
- Patient Knowledge(Up to 3 weeks)
- Concordance Between Personal Values and Surgery Received(Up to 3 weeks)