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; 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.

项目摘要 近90％的低风险甲状腺甲状腺癌患者进行了总甲状腺切除术，该治疗选择 尽管发病率最高，尽管侵入性较低的选择提供了同等的复发和生存。 这些患者的过度治疗导致严重的患者伤害和大量成本。目前，患者 有未满足的信息需求，有助于甲状腺全切除术的摄取。低风险的患者 甲状腺乳头状癌将受益于满足其信息需求并增加的干预措施 他们参加决策过程的能力。该建议是支持我们的长期的关键步骤 通过介入手术决策来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的新颖干预措施，其中包括（1）并排图表， 基于证据的信息，比较了低风险甲状腺癌的所有三种管理选项，包括 预期结果和（2）一个问题提示列表，其中包含要考虑询问的关键问题 外科医生。干预措施基于社会认知理论，旨在提高患者对 治疗方案及其结果，患者激活以及决策的自效。这个建议 将在一个卫生系统的三个诊所地点进行驾驶。我们提出了一个随机的飞行员可行性 50例低风险甲状腺甲状腺癌患者的对照试验，以评估 cquple（AIM 1）并表征结果的分布（AIM 2）。 拟议的研究结果将提供为准备未来大型，大型的初步数据 比例务实的有效性试验，以测试Cquple对患者总甲状腺切除术选择的影响。 cquple 是一种低成本，可扩展性，以患者为导向的干预措施，是创新的，因为它结合了两个免费 通过不同的机制来满足患者的信息和决策需求的组件。 研究很重要，因为低危甲状腺癌患者的甲状腺总切除术率降低 有可能减少患者伤害并改善长期结局。我们的多学科团队 与行为干预设计和测试有关的成功合作和经验的历史 随机化对照试验使我们有好处，以实现该奖项的目标。