护士AMIE随机对照试验解决农村晚期癌症患者的症状管理：解决日常生活中的恶性肿瘤。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-07-10 DOI:10.1016/j.cct.2025.108005

Kathryn H. Schmitz , Stephen Baker , Samantha J. Werts-Pelter , Shawn Doerksen , Charity G. Patterson , Mohammed Ahmed , Ray Scalise , Alex Vincent , Caitlyn Desroches , Michele Sobolewski , Rebecca Celebre , Sara Garrett , Nicole Stout , William A. Calo , Shannon Fisher , Erica Schleicher , Brett Gordon , Praveen Kumar

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引用次数: 0

摘要

背景：评估和管理症状对晚期癌症患者的生存有好处。然而，农村癌症患者难以获得治疗症状的服务。技术可能提供一种解决方案；然而，专门利用基于技术的解决方案在农村环境中提供高质量支持性护理的工作很少。方法：护士AMIE （Addressing malignant tumours in individual Everyday）是一项为期2年的III期随机对照疗效试验，旨在调查344名生活在农村地区的晚期癌症患者使用基于片剂的症状管理和支持性护理干预来提高总体生存率。参与者按1:1的比例随机分配到护士AMIE干预组或接受书面支持性护理材料的常规护理组。干预参与者被要求每天使用研究提供的片剂访问护士AMIE应用程序，回答有关他们疼痛、疲劳、睡眠和痛苦程度的症状问卷。在收到AMIE护士的共情反应后，参与者被提供了一个指导和谐的自我护理干预来解决他们的症状。该试验检测到两组在2 年的总生存率有19. %的差异。次要结局包括症状严重程度、功能、生活质量、患者报告的结局和成本-效果。结论：护士AMIE是第一个应用并严格评估持续症状评估和管理对农村晚期癌症患者总生存影响的试验。护士AMIE试验的结果将为在服务不足的农村人口中提供高质量、基于技术的支持性护理方案的有效性提供证据。临床试验：政府注册号NCT05221606。

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Nurse AMIE randomized controlled trial to address symptom management among rural advanced Cancer patients: Addressing malignancies in everyday life

Background

Assessing and managing symptoms has a survival benefit for patients with advanced cancer. However, rural cancer patients have difficulty accessing services to address symptoms. Technology may offer one solution; however, little work has been done to specifically leverage technology-based solutions to deliver high quality supportive care in rural settings.

Methods

Nurse AMIE (Addressing Malignancies in Individuals Everyday) is a 2-year, Phase III randomized controlled efficacy trial to investigate the use of a tablet-based symptom management and supportive care intervention to improve overall survival among 344 advanced cancer patients living in rural areas. Participants are randomized on a 1:1 basis to the Nurse AMIE intervention or a usual care group that receives a binder with written supportive care materials. Intervention participants are asked to access the Nurse AMIE application daily using the study-provided tablet to answer symptom questionnaires regarding their level of pain, fatigue, sleep, and distress. After receiving an empathic response from Nurse AMIE, participants are offered a guideline concordant self-care intervention to address their symptoms. The trial is powered to detect a 19 % difference in overall survival between groups at 2 years. Secondary outcomes include symptom severity, function, quality of life, patient-reported outcomes, and cost-effectiveness.

Conclusions

Nurse AMIE is the first trial to apply and rigorously assess the effect of ongoing symptom assessment and management on overall survival among rural, advanced cancer patients. Results from the Nurse AMIE trial will provide evidence of the efficacy of delivering a high-quality, technology-based supportive care program among underserved rural populations.

ClinicalTrials.gov registration number NCT05221606

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.