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: 10698150
• 负责人: Rachel Adams Greenup
• 金额: $ 53.75万
• 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/10698150
• 关键词: Adjuvant Therapy; 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; 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 testing; effectiveness/implementation design; financial toxicity; implementation barriers; implementation evaluation; implementation intervention; implementation outcomes; improved; innovation; malignant breast neoplasm; novel; patient oriented; peace; pragmatic study; 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.

项目总结/摘要 在美国，患有早期乳腺癌的年轻女性越来越多地选择接受 切除未受影响的乳房，称为对侧预防性乳房切除术（CPM）或双侧 （“双”）乳房切除术。CPM的临床益处（例如，没有生存利益）是最小的， 记录的伤害，包括手术并发症风险增加和潜在的负面质量 生活的后遗症。此外，美国乳腺外科医师协会和明智选择指南 不建议在患有单侧乳腺癌的平均风险女性中常规使用CPM。之前 研究表明，乳腺癌手术的风险和益处并没有得到最佳的评估， 沟通，一些妇女对乳腺癌的风险有不准确的看法， 影响他们对手术的选择生命阶段的特定因素（例如，母乳喂养，身体形象）可以使手术 对青年妇女来说，决定特别复杂，青年妇女报告说， 关于手术的决定最佳支持年轻女性做出乳腺癌的决定 我们开发了CONSYDER，这是一种基于网络的决策支持工具，专为年轻人的独特关注而设计。 患者在我们的试点研究中，所有使用CONSYDER的女性都发现它有助于她们了解利弊 并围绕这一高度偏好敏感的决定阐明他们的价值观。CONSYDER创新于 它的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 作为决策工具的一部分。这些资源受到患者的重视，证明了 这种方法承认他们的社会心理需求。我们现在提出一个务实的， 采用II型混合有效性-实施设计的阶梯楔形多中心试验。我们将 在800名年轻女性中测试CONSYDER在减少术前决策冲突方面的有效性 在耶鲁Smilow癌症中心，Weill Cornell Medicine，Dana-Farber Cancer 研究所和杜克癌症研究所。同时，我们将采用混合方法，包括调查 与患者和提供者进行半结构化访谈，以评估 考虑一下。实施结果将包括交付的可行性、跨站点的采用和保真度， 关键特征的吸收和可持续性。我们的务实研究将检验 旨在促进共同决策和减少年轻妇女决策冲突的干预措施， 乳腺癌我们期望拟议研究的结果不仅能证明这一做法的有效性， 新的干预措施，而且还告知CONSYDER的最佳交付和更广泛的传播， 以患者为中心的支持，为年轻女性乳腺癌患者提供最高质量的偏好敏感决策 癌症面临手术