A Pilot Feasibility Study of an Intervention to Decrease Overtreatment of Low-risk Thyroid Cancer

减少低危甲状腺癌过度治疗的干预措施试点可行性研究

• 批准号: 10729147
• 负责人: Susan C Pitt
• 金额: $ 8.4万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10729147
• 关键词: Address; Age; American; Award; Awareness; Behavior; Behavior Therapy; Cancer Survivor; Caregivers; Clinic; Clinic Visits; Clinical; Clinical Trials; Collaborations; Communication; Communities; Consult; Data; Data Collection; Decision Making; Deimplementation; Diagnosis; Expectancy; Fatigue; Feasibility Studies; Future; Goals; Health; Health system; Individual; Intervention; Intervention Studies; Interview; Knowledge; Language; Longevity; Malignant Neoplasms; Malignant neoplasm of thyroid; Measures; Methodology; Mission; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Papillary thyroid carcinoma; Participant; Patient Preferences; Patients; Pilot Projects; Positioning Attribute; Procedures; Process; Protocols documentation; Provider; Qualifying; Quality of life; Randomized; Randomized, Controlled Trials; Readiness; Recommendation; Recording of previous events; Recurrence; Research; Risk; Self Efficacy; Side; Site; Structure; Surgeon; Survivors; Testing; Thyroid Gland; Thyroidectomy; Time; Visit; Vocal Cord Paralysis; Work; acceptability and feasibility; cancer care; care costs; cohort; cost; disability; evidence base; experience; improved; innovation; intervention effect; multidisciplinary; novel; overtreatment; pragmatic efficacy trial; primary outcome; psychosocial; recruit; secondary outcome; shared decision making; social cognitive theory; therapy design; treatment as usual; treatment choice; treatment risk; ultrasound; uptake

PROJECT SUMMARY Nearly 90% of patients with low-risk papillary thyroid cancer undergo total thyroidectomy, the treatment option with the greatest morbidity, even though less invasive options offer equivalent recurrence and survival. Overtreatment of these patients results in significant patient harm and substantial costs. Currently, patients have unmet informational needs that contribute to the uptake of total thyroidectomy. Patients with low-risk papillary thyroid cancer would benefit from an intervention that meets their informational needs and increases their ability to participate in the decision-making process. This proposal is a key step to support our longer-term goal of reducing overtreatment of low-risk thyroid cancer by intervening on surgical decision making. Our research team developed a novel intervention called CQUPLE, which includes (1) a Chart of side-by-side, evidence-based information comparing all three management options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon. The intervention is grounded in social cognitive theory and aims to increase patient awareness of treatment options and their outcomes, patient activation, and self-efficacy for decision making. This proposal will pilot CQUPLE at three clinic sites in a single health system. We propose a pilot feasibility randomized controlled trial in 50 patients with low-risk papillary thyroid cancer to evaluate the feasibility and acceptability of CQUPLE (Aim 1) and characterize the distribution of outcomes (Aim 2). The results of the proposed research will provide the preliminary data necessary to prepare for a future, large- scale pragmatic efficacy trial to test the effect of CQUPLE on patients’ choice for total thyroidectomy. CQUPLE is a low-cost, scalable, patient-directed intervention that is innovative because it combines two complimentary components that work to meet patients’ informational and decisional needs through different mechanisms. The research is significant because reducing rates of total thyroidectomy for patients with low-risk thyroid cancer has the potential to decrease patient harm and improve long-term outcomes. Our multidisciplinary team’s history of successful collaboration and experience in behavioral intervention design and testing with randomizes controlled trials make us well positioned to achieve the aims of this award.

项目总结 近90%的低风险乳头状甲状腺癌患者接受了全甲状腺切除术，治疗方案 发病率最高，尽管侵袭性较小的选择可提供同等的复发率和生存率。 对这些患者的过度治疗会导致严重的患者伤害和巨大的成本。目前，患者 有未满足的信息需求，有助于接受全甲状腺切除术。低风险患者 乳头状甲状腺癌将从满足他们的信息需求和增加的干预中受益 他们参与决策过程的能力。这项提议是支持我们长期发展的关键一步 通过干预手术决策减少低风险甲状腺癌过度治疗的目标。 我们的研究团队开发了一种名为CQUPLE的新型干预方法，它包括(1)并排图表， 比较所有三种低风险甲状腺癌治疗方案的循证信息，包括 预期结果和(2)包含要考虑询问的关键问题的问题提示列表 外科医生。干预以社会认知理论为基础，旨在提高患者对 治疗方案及其结果、患者激活度和决策的自我效能。这项建议 将在一个单一卫生系统的三个诊所地点试点CQUPLE。我们提出了一种随机试点的可行性 50例低危乳头状甲状腺癌的临床对照研究 CQUPLE(目标1)，并描述成果的分布(目标2)。 拟议的研究结果将提供必要的初步数据，为未来的大型- 量表实用疗效试验，以检验CQUPLE对患者选择全甲状腺切除术的影响。持续时间 是一种低成本、可扩展的、以患者为导向的干预措施，它具有创新性，因为它结合了免费的 通过不同的机制满足患者的信息和决策需求的组件。这个 这项研究意义重大，因为降低了低风险甲状腺癌患者的全甲状腺切除率 有可能减少对患者的伤害并改善长期结果。我们的多学科团队 在行为干预设计和测试方面的成功合作历史和经验 随机对照试验使我们能够很好地实现该奖项的目标。