Developing a Decision Tool for Chemotherapy in Older Women with Early Stage Breast Cancer

为患有早期乳腺癌的老年女性开发化疗决策工具

• 批准号: 10197035
• 负责人: Meghan Sri Karuturi
• 金额: $ 25.06万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10197035
• 关键词: Adverse effects; Advocate; Age; Benefits and Risks; Breast Cancer Risk Factor; Breast Cancer Treatment; Cancer Patient; Clinical; Clinical Trials Design; Collaborations; Communication; Complex; Conflict (Psychology); Consensus; County; County Hospitals; Data; Decision Aid; Decision Making; Development; Disease; Education; Elderly; Evaluation; Exposure to; Feedback; Feeling; Goals; Guidelines; Health Personnel; Hospitals; International; Knowledge; Life Expectancy; Literature; Measures; Medical; Methodology; Methods; Nurses; Older Population; Oncologist; Outcome; Patient Care; Patient Outcomes Assessments; Patient Preferences; Patients; Perception; Physicians; Pilot Projects; Probability; Process; Prognosis; Provider; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Research; Research Personnel; Risk; Role; Sampling; Science; Toxicity due to chemotherapy; Training Activity; Treatment Side Effects; Treatment outcome; Uncertainty; University of Texas M D Anderson Cancer Center; Visit; Woman; Women Physicians; Work; acceptability and feasibility; chemotherapy; clinical risk; comorbidity; control trial; design; efficacy evaluation; expectation; experience; field study; health communication; human old age (65+); improved; malignant breast neoplasm; older patient; older women; patient oriented; patient population; preference; recruit; safety net; shared decision making; skills; support tools; tool; treatment risk; usual care arm

PROJECT SUMMARY/ABSTRACT The chemotherapy decision-making process in older women with early-stage breast cancer is complex. Although older women derive a similar degree of benefit from chemotherapy as compared to their younger counter-parts, there are other issues such as medical comorbidities and unique adverse effects that may influence the recommendations of physicians and preferences of patients, subsequently impacting treatment outcomes. Currently, there are no decision aids available to guide patients in considering tradeoffs between quality of life and prognosis conferred by their disease and treatment. The literature supports that older patients desire more active roles in decision-making, and a critical need exists for tools to facilitate patient- centered communication and shared decision-making. Evidence supports that decision aids enhance shared- decision making processes. In the proposed project, I will develop a decision aid to meet the information and clinical needs of older adult women making breast-cancer treatment decisions, and support their physician in navigating this conversation. The tool will include two components: (1) a physician-facing component that will incorporate validated breast-cancer risk outcomes, and (2) a patient-facing component that will include an include education (overview of the disease, goals of therapy), description of benefits/risks of treatment, feedback on tailored outcome probabilities, and values clarification. My overall hypothesis is that a decision support tool will provide patients and physicians with tailored information regarding the risks and benefits of chemotherapy and values clarification to support high quality, shared decisions. An advisory panel composed of patients, oncologists, geriatricians, nurses and patient advocates will provide regular feedback throughout the development process and engage in an iterative process of development. We will subsequently evaluate the tool for acceptability and feasibility through a field test of 20 patients. After incorporating feedback from the field test to create a finalized version of the tool, we will carry out a cluster-randomized pilot study that will include randomization to a usual-care arm with the objective of evaluating the efficacy of the decision support tool by measuring patient-reported outcomes of decisional conflict, knowledge, and a measure of the decision- process/approach. Ultimately, the results of this project will inform a larger randomized control trial to assess whether the decision tool improves patient knowledge, decision quality/processes, and quality of life. Furthermore, through my work on this project and the proposed training activities, I will strengthen by skill-set in decision science, health communication, qualitative/mixed-methods methodology and clinical trial design which allow me to transition to my long-term goal of becoming an established independent investigator.

项目总结/摘要 早期乳腺癌老年妇女的化疗决策过程是复杂的。 虽然老年妇女从化疗中获益的程度与年轻妇女相似， 相反，还有其他问题，如医学合并症和独特的不良反应， 影响医生的建议和患者的偏好，随后影响治疗 结果。目前，没有决策辅助工具可用于指导患者考虑以下因素之间的权衡： 生活质量和预后由他们的疾病和治疗。有文献表明， 患者希望在决策中发挥更积极的作用，迫切需要工具来帮助患者， 集中沟通和共同决策。有证据表明，决策辅助工具可以增强共享- 决策过程。在拟议的项目中，我将开发一个决策辅助工具，以满足信息和 老年妇女的临床需要，使乳腺癌治疗的决定，并支持他们的医生， 引导这次谈话该工具将包括两个部分：（1）面向医生的部分， 纳入经验证的乳腺癌风险结果，以及（2）面向患者的组件，包括 包括教育（疾病概述、治疗目标）、治疗获益/风险描述， 对定制结果概率的反馈，以及价值观的澄清。我的总体假设是 支持工具将为患者和医生提供有关风险和受益的定制信息， 化疗和价值观的澄清，以支持高质量，共享的决策。一个咨询小组， 患者，肿瘤学家，老年病学家，护士和患者倡导者将在整个过程中定期提供反馈 开发过程，并参与开发的迭代过程。我们随后将评估 该工具的可接受性和可行性，通过现场测试的20名患者。在采纳了 为了创建该工具的最终版本，我们将进行一项群集随机试点研究， 包括随机分配到常规治疗组，目的是评估决策支持的有效性 工具，通过测量患者报告的决策冲突结果，知识和决策的衡量标准- 过程/方法。最终，该项目的结果将为更大的随机对照试验提供信息，以评估 决策工具是否改善了患者知识、决策质量/过程和生活质量。 此外，通过我在这个项目上的工作和拟议的培训活动，我将加强技能组合， 在决策科学，健康传播，定性/混合方法学和临床试验设计 这使我能够过渡到我的长期目标，成为一个既定的独立调查员。