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: 10460514
• 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 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10460514
• 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; 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.

项目摘要/摘要 患有早期乳腺癌的老年女性的化疗决策过程是复杂的。 尽管与年轻女性相比，老年女性从化疗中获得的益处程度相似 相应地，还有其他问题，如医疗合并症和独特的不良反应，可能 影响医生的建议和患者的偏好，从而影响治疗 结果。目前，还没有可用的决策辅助工具来指导患者在以下方面进行权衡 疾病和治疗对患者生活质量和预后的影响。文献支持那个更古老的 患者希望在决策中发挥更积极的作用，并且迫切需要工具来促进患者- 以沟通为中心，共享决策。有证据表明，决策有助于加强共享- 决策过程。在提议的项目中，我将开发一个决策辅助工具，以满足信息和 制定乳腺癌治疗决策的老年妇女的临床需求，并支持她们的医生 在这场对话中导航。该工具将包括两个组件：(1)面向医生的组件，它将 纳入经过验证的乳腺癌风险结果，以及(2)面向患者的组件，其中将包括 包括教育(疾病概述、治疗目标)、治疗益处/风险描述、 反馈量身定做的结果概率，并澄清价值。我的总体假设是，一个决定 支持工具将为患者和医生提供关于以下风险和好处的量身定制的信息 化疗和价值澄清，以支持高质量的共享决策。由以下成员组成的咨询小组 患者、肿瘤学家、老年医生、护士和患者权益倡导者将在整个过程中提供定期反馈 开发过程并从事一个迭代的开发过程。我们随后将评估 通过对20名患者的现场测试，该工具的可接受性和可行性。在纳入了来自 现场测试为了创建该工具的最终版本，我们将进行一项群组随机试点研究，该研究将 包括随机化到普通护理组，目的是评估决策支持的效果 通过测量患者报告的决策冲突的结果、知识和决策的测量- 流程/方法。最终，这个项目的结果将提供给一个更大的随机对照试验来评估 决策工具是否提高了患者的知识、决策质量/流程和生活质量。 此外，通过我在这个项目上的工作和拟议的培训活动，我将通过技能集来加强 决策科学、健康传播、定性/混合方法方法学和临床试验设计 这让我可以过渡到我的长期目标，成为一名成熟的独立调查员。