Individualizing Decision Quality for Patients With Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 537
- 试验地点
- 2
- 主要终点
- Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.
研究概览
简要总结
This study examines the impact of an online decision tool for patients with early stage invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas. Participants will be randomized to receive either a basic version of a decision tool (similar to existing website with breast cancer information) or an enhanced version (featuring a knowledge building component, a values clarification exercise, and a patient activation module). Our hypothesis is that patients who use the enhanced version of the tool will have greater knowledge of their test and treatment options, have a higher rate of high quality (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the decision-making process.
详细描述
Patients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. Currently many of these decisions do not meet the definition of a high quality decision, defined as one that is both informed (i.e., based on an accurate understanding of the treatment risks and benefits) and preference-concordant (i.e., consistent with the patients' underlying preferences). Moreover, the introduction of evaluative tests has made these decisions more complicated for many patients. There is a need to improve the quality of locoregional and systemic treatment decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. Ensuring patients can deliberate effectively about these decisions, assert their views and communicate with their clinicians is likely to improve their overall decision preparedness and satisfaction. This study will focus on the third pillar of individualized care by evaluating the impact of an innovative decision tool on locoregional and systemic therapy decision making for newly diagnosed breast cancer patients. The innovative online decision tool has been developed and tested over the past two years by the CanSORT team (R21 CA129859). Pilot data suggests that this tool has a positive impact on patient knowledge and decision outcomes. The goal of this study is to evaluate the impact of this tool, after it is enhanced in collaboration with our Communication and Dissemination Core, on the quality of decision making for locoregional and systemic breast cancer treatment decision making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 84 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage 1-2 invasive breast cancer diagnosis,
- •Ability to read English
排除标准
- 未提供
研究组 & 干预措施
CanSORT Online Tool
Comprehensive decision tool
干预措施: CanSORT Online Tool (Other)
Static version of CanSORT tool
Static version (non-interactive) version of CanSORT decision tool
干预措施: Static version of CanSORT tool (Other)
结局指标
主要结局
Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.
时间窗: 4-5 weeks from date of enrollment
Self reported knowledge about locoregional treatment using a 5 item Breast Cancer Knowledge Measure (adapted). A binary knowledge indicator was created for all patients whereby high knowledge indicated for patients scoring greater than 80% on the item scale. The binary knowledge variable was analyzed for intervention effect using both unadjusted and adjusted logistic mixed model regression.
Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant
时间窗: 4-5 weeks from date of enrollment
Self reported values were evaluated using a 5 item question set adapted from Decision Quality Instrument. The questions determined patient desire for outcomes such as keeping their natural breast and avoiding radiation on a scale from 0 to 10. Patients were classified as values-concordant if their actual treatment aligned with their values score predicted treatment and otherwise were classified as non-concordant. The binary values-concordance variable was modeled as a function of intervention effect using both unadjusted and adjusted logistic mixed model regression.
次要结局
- Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment(4-5 weeks from date of enrollment)
- Patient Subjective Decision Quality for Systemic Breast Cancer Treatment(9 months after enrollment)
- Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer(9 months after enrollment)
- Patient Preparedness Decision Making for Locoregional Treatment.(4-5 weeks from date of enrollment)
- Patient Deliberation for Locoregional Breast Cancer Treatment.(4-5 weeks from date of enrollment)
- Patient Preparedness Decision Making for Systemic Treatment(9 months after enrollment)
研究者
Sarah T. Hawley
Associate Professor
University of Michigan