Effectiveness and implementation of a decision support tool to improve surgical decision making in young women with breast cancer

决策支持工具的有效性和实施，以改善年轻乳腺癌女性的手术决策

• 批准号: 10522409
• 负责人: Rachel Adams Greenup
• 金额: $ 60.61万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-06 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10522409
• 关键词: Adjuvant; Adoption; Affect; Age; American; Anxiety; Benefits and Risks; Bilateral; Body Image; Breast; Breast Cancer Patient; Breast Cancer Risk Factor; Breast Feeding; Cancer Center; Caring; Clinical; Communication; Complex; Conflict (Psychology); Consolidated Framework for Implementation Research; Consult; Contralateral; Dana-Farber Cancer Institute; Data; Decision Aid; Decision Making; Diagnosis; Effectiveness; Effectiveness of Interventions; Fertility; Future; Goals; Guidelines; Health system; Healthcare Systems; Institutes; Intervention; Interview; Knowledge; Life; Literature; Malignant Neoplasms; Mastectomy; Medicine; Methods; Mind; Multicenter Trials; Online Systems; Operative Surgical Procedures; Outcome; Patient Outcomes Assessments; Patients; Penetration; Perception; Perioperative complication; Personal Autonomy; Phase; Pilot Projects; Procedures; Provider; Quality of life; Radiation; Randomized; Recommendation; Recurrence; Regrets; Reporting; Research; Resources; Risk; Self Efficacy; Sexuality; Site; Societies; Structure; Supportive care; Surgeon; Surgical complication; Surveys; United States; Unnecessary Surgery; Vulnerable Populations; Woman; Work; breast cancer diagnosis; breast lumpectomy; cancer surgery; clinical practice; cost; design; effectiveness evaluation; effectiveness implementation design; effectiveness implementation study; effectiveness testing; financial toxicity; implementation barriers; implementation evaluation; implementation intervention; implementation outcomes; improved; innovation; malignant breast neoplasm; novel; patient oriented; peace; preference; prophylactic mastectomy; psychosocial; risk perception; shared decision making; stress management; support tools; surgical risk; surveillance imaging; therapy design; tool; treatment as usual; trend; uptake; young adult; young woman

Project Summary/Abstract In the United States, young women with early-stage breast cancer are increasingly choosing to have their unaffected breast removed, a procedure known as contralateral prophylactic mastectomy (CPM) or bilateral (“double”) mastectomy. The clinical benefits of CPM (e.g., no survival benefit) are minimal and there are documented harms, including an increased risk of surgical complications and the potential for negative quality of life sequelae. Additionally, the American Society of Breast Surgeons and Choosing Wisely guidelines recommend against the routine use of CPM among average risk women with unilateral breast cancer. Prior research has suggested that the risks and benefits of breast cancer surgery are not being optimally communicated and that some women have inaccurate perceptions about breast cancer risks that are likely impacting their choice of surgery. Life-stage specific factors (e.g., breastfeeding, body image) can make surgical decisions particularly complex for young women and young women report high levels of decisional conflict regarding the surgical decision. To optimally support young women making decisions about breast cancer surgery, we developed CONSYDER, a web-based decision support tool tailored to the unique concerns of young patients. In our pilot study, all women who used CONSYDER found it helped them understand the pros and cons of surgery and clarify their values around this highly preference sensitive decision. CONSYDER is innovative in its approach to decision support in that integrates supportive care resources to help manage stress and anxiety around diagnosis as part of the decision tool. These resources were valued by patients, demonstrating the acceptability of this approach that acknowledges their psychosocial needs. We are now proposing a pragmatic, stepped-wedge, multicenter trial that incorporates a Type II hybrid effectiveness-implementation design. We will test the effectiveness of CONSYDER in reducing decisional conflict before surgery among 800 young women seeing a breast cancer surgeon at Yale Smilow Cancer Center, Weill Cornell Medicine, Dana-Farber Cancer Institute, and Duke Cancer Institute. Concurrently, we will use a mixed-methods approach, including surveys and semi-structured interviews with patients and providers, to evaluate the value and implementation of CONSYDER. Implementation outcomes will include feasibility of delivery, adoption and fidelity across sites, uptake of key features, and sustainability. Our pragmatic study will test the effectiveness and implementation of an intervention designed to promote shared decision-making and reduce decisional conflict in young women with breast cancer. We expect findings from the proposed study not only to demonstrate the effectiveness of this novel intervention but also to inform the optimal delivery and broader dissemination of CONSYDER, enabling patient-centered support for the highest quality preference-sensitive decisions for young women with breast cancer facing surgery.

项目概要/摘要 在美国，越来越多患有早期乳腺癌的年轻女性选择接受乳腺癌治疗。 切除未受影响的乳房，这种手术称为对侧预防性乳房切除术 (CPM) 或双侧乳房切除术 （“双”）乳房切除术 CPM 的临床益处（例如，无生存益处）微乎其微，而且存在一定的风险。 记录在案的危害，包括手术并发症风险增加和潜在的负面质量 此外，美国乳腺外科医生协会和明智选择指南。 建议不要在患有单侧乳腺癌的普通风险女性中常规使用 CPM。 研究表明，乳腺癌手术的风险和益处并未达到最佳状态 沟通，一些女性对乳腺癌风险的看法可能不准确 影响他们选择手术的生命阶段的特定因素（例如母乳喂养、身体形象）可以进行手术。 年轻女性的决策尤其复杂，而且年轻女性报告决策冲突程度很高 为年轻女性做出有关乳腺癌的决定提供最佳支持。 外科手术中，我们开发了 CONSYDER，这是一种基于网络的决策支持工具，专门针对年轻人的独特问题而定制 在我们的试点研究中，所有使用 CONSYDER 的女性都发现它可以帮助她们了解利弊。 CONSYDER 的创新在于围绕这一高度敏感的偏好决定进行手术并阐明其价值观。 其决策支持方法整合了支持性护理资源，以帮助管理压力和焦虑 围绕诊断作为决策工具的一部分，这些资源受到患者的重视，表明了 这种方法的可接受性，承认他们的社会心理需求。我们现在提出一种务实的、 阶梯楔形、多中心试验，采用 II 型混合有效性实施设计。 测试 CONSYDER 在减少 800 名年轻女性术前决策冲突方面的有效性 在耶鲁大学斯米洛癌症中心、威尔康奈尔医学院、丹娜法伯癌症中心看乳腺癌外科医生 同时，我们将使用混合方法，包括调查。 以及与患者和提供者的半结构化访谈，以评估价值和实施情况 CONSYDER。实施结果将包括跨站点交付、采用和保真度的可行性， 我们的务实研究将测试关键功能的有效性和实施情况。 旨在促进年轻女性共同决策并减少决策冲突的干预措施 我们期望拟议研究的结果不仅能证明这项研究的有效性。 新颖的干预措施，同时也为 CONSYDER 的最佳交付和更广泛传播提供信息，使 以患者为中心，为患有乳腺癌的年轻女性提供最高质量的偏好敏感决策支持 癌症面临手术。