乳腺癌和心血管疾病药物治疗公平性改善（IMPACT）随机临床试验的原理与设计
Rationale and design of the IMProving Adherence to medications for breast Cancer and cardiovascular disease equiTably (IMPACT) randomized clinical trial.
作者信息
Sathe Claire, DeStephano David, Lee Shing, West Harry, Beauchemin Melissa, Accordino Melissa, Liyanage-Don Nadia, Crew Katherine D, Kukafka Rita, Harden Erik, Hershman Dawn L, Kronish Ian M
机构信息
Columbia University Irving Medical Center, New York, NY, United States of America.
Columbia University Irving Medical Center, New York, NY, United States of America.
出版信息
Contemp Clin Trials. 2025 Jul 11;156:108009. doi: 10.1016/j.cct.2025.108009.
BACKGROUND
Cardiovascular disease (CVD) is a leading cause of mortality in patients with early-stage breast cancer (BC), many of whom are prescribed endocrine therapy (ET) to prevent BC recurrence. Yet, nonadherence to ET and CVD medications is common among BC survivors, particularly in underserved populations at high risk for adverse outcomes. Little is known about how to equitably improve medication adherence for multiple chronic conditions.
METHODS
The IMProving Adherence to Medications for Breast Cancer and Cardiovascular Disease EquiTably (IMPACT) trial is an investigator-initiated, single-center (multisite), two-arm randomized trial. Patients in BC clinics are screened for nonadherence to ET and CVD medications (antihypertensive or statin) using prescription fill data and a self-report questionnaire. A total of 300 patients with stage I-III BC who screen positive for nonadherence will be randomized to receive an equity-focused multicomponent medication adherence intervention versus minimally-enhanced usual care. The intervention includes nurse-led medication reconciliation, a one-time optional training in the use of the electronic patient portal and a smartphone adherence-focused application, and two structured pharmacist counseling sessions tailored to patients' adherence barriers. The control group receives medication reconciliation only. The primary outcome is adherence to ET and CVD medications by self-report and pharmacy fill data at 28 weeks. Key secondary outcomes include medication adherence at 52 weeks, adherence to individual medication classes, CVD risk factor control (BP, LDL), and patient-reported outcomes.
DISCUSSION
The IMPACT trial will determine the effect of a multicomponent medication adherence intervention that targets nonadherent patients and is tailored to individual-level reasons for nonadherence.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT05496829).
背景
心血管疾病（CVD）是早期乳腺癌（BC）患者死亡的主要原因，其中许多患者被开具内分泌治疗（ET）药物以预防乳腺癌复发。然而，乳腺癌幸存者中不坚持服用ET和心血管疾病药物的情况很常见，尤其是在面临不良后果高风险的服务不足人群中。对于如何公平地提高多种慢性病患者的药物依从性，我们知之甚少。
方法
“公平改善乳腺癌和心血管疾病药物依从性（IMPACT）试验”是一项由研究者发起的单中心（多站点）双臂随机试验。使用处方配药数据和一份自我报告问卷，对乳腺癌诊所的患者进行ET和心血管疾病药物（抗高血压药或他汀类药物）不依从情况的筛查。总共300名I-III期乳腺癌且筛查出不依从呈阳性的患者将被随机分组，分别接受以公平为重点的多组分药物依从性干预或最低限度强化的常规护理。干预措施包括护士主导的药物重整、一次使用电子患者门户和一款以智能手机为基础的聚焦依从性应用程序的可选培训，以及根据患者的依从性障碍量身定制的两次结构化药剂师咨询会议。对照组仅接受药物重整。主要结局是在28周时通过自我报告和药房配药数据得出的ET和心血管疾病药物依从性。关键次要结局包括52周时的药物依从性、各类药物的依从性、心血管疾病危险因素控制（血压、低密度脂蛋白）以及患者报告的结局。
讨论
IMPACT试验将确定一种针对不依从患者且根据个体不依从原因量身定制的多组分药物依从性干预措施的效果。
试验注册
ClinicalTrials.gov（NCT05496829）。
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