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Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial

机译:提高乳腺癌患者对内分泌激素治疗的依从性:一项随机对照试验的研究方案

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Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all breast cancer patients with hormone receptor-positive tumors, which represent 75% of all breast cancer diagnoses. Long-term use of EHT reduces recurrence rates and nearly halves the risk of death during the second decade after diagnosis. Despite the proven benefits, about 33% of women receiving EHT do not take their medication as prescribed. This causes an increase in the risk for recurrence and death.To promote adherence to EHT among breast cancer patients, this study will develop and pilot-test an intervention consisting of 1) a bilingual, culturally tailored, personalized, interactive smartphone application (app); and 2) support from a patient navigator. The control group will receive usual care. This 2-group randomized control trial will recruit 120 breast cancer patients receiving EHT at the Mays Cancer Center at UT Health San Antonio. The two-year study will have 3-time assessments (baseline, 3 and 6 months).This theory-based intervention will empower patients' self-monitoring and management. It will facilitate patient education, identification/reporting of side effects, delivery of self-care advice, and simplify communication between the patient and the oncology team. The ultimate goal of this innovative multi-communication intervention is to improve overall survival and life expectancy, enhance quality of life, reduce recurrence, and decrease healthcare cost. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using EHT and other oral anticancer agents.
机译:辅助内分泌激素治疗(EHT)非常有效,适用于几乎所有患有激素受体阳性肿瘤的乳腺癌患者,占所有乳腺癌诊断的75%。在诊断后的第二个十年中,长期使用EHT可以降低复发率,并使死亡风险降低近一半。尽管已证明有益处,但接受EHT的女性中约有33%的人未按处方服用药物。为提高乳腺癌患者对EHT的依从性,本研究将开发和试点干预措施,其中包括1)双语,文化定制,个性化,交互式智能手机应用程序(app) ;和2)病人导航仪的支持。对照组将得到常规护理。这项2组随机对照试验将招募120名在UT Health San Antonio的Mays癌症中心接受EHT的乳腺癌患者。这项为期两年的研究将进行3次评估(基线,3个月和6个月),这种基于理论的干预将增强患者的自我监控和管理能力。这将有助于患者教育,副作用的识别/报告,自我保健建议的提供,并简化患者与肿瘤学团队之间的沟通。这种创新的多方交流干预措施的最终目标是提高整体生存率和预期寿命,提高生活质量,减少复发率并降低医疗保健成本。预期的结果是可扩展的,基于证据的,易于传播的干预措施,对于使用EHT和其他口服抗癌药的患者可能具有广泛的用途。

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