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