Oncological Palliative Medicine, Section Oncology, Department of Internal Medicine and Palliative Care Centre, Cantonal Hospital St, Gallen, Rorschacherstrasse 95, St, Gallen 9007, Switzerland.
BMC Palliat Care. 2012 Sep 24;11:19. doi: 10.1186/1472-684X-11-19.
In patients with advanced, incurable cancer, anticancer treatment may be used to alleviate cancer-related symptoms, but monitoring of them in daily practice is rarely done. We aim to test the effectiveness of a real-time symptom and syndrome assessment using the E-MOSAIC software installed in handheld computer generating a longitudinal monitoring sheet (LoMoS) provided to the oncologists in a phase III setting.
In this prospective multicentre cluster randomized phase-III trial patients with any incurable solid tumor and having defined cancer related symptoms, who receive new outpatient chemotherapy in palliative intention (expected tumor-size response rate ≤20%) are eligible. Immediately before the weekly visit to oncologists, all patients complete with nurse assistance the E-MOSAIC Assessment: Edmonton Symptom Assessment Scale, ≤3 additional symptoms, estimated nutritional intake, body weight, Karnofsky and medications for pain and cachexia. Experienced oncologists will be randomized to receive the LoMoS or not. To minimize contamination, LoMoS are removed from the medical charts after visits. Primary endpoint is the difference in global quality of life (items 29 & 30 of EORTC-QlQ-C30) between baseline and last study visit at week 6, with a 10 point between-arm difference considered to be clinically relevant. 20 clusters (=oncologists) per treatment arm with 4-8 patients each are aimed for to achieve a significance level of 5% and a power of 80% in a mixed model approach. Selected co- variables are included in the model for adjustment. Secondary endpoints include patient-perceived patient-physician communication symptom burden over time, and oncologists' symptom management performance (predefined thresholds of symptoms compared to oncologists' pharmacological, diagnostic or counselling actions [structured chart review]).
This trial will contribute to the research question, whether structured, longitudinal monitoring of patients' multidimensional symptoms, indicators for symptom management, and clinical benefit outcomes can influence patients' quality of life and symptom distress, in a setting of routine oncology practice.
Current Controlled Trials NCT00477919.
在晚期、无法治愈的癌症患者中，抗癌治疗可能用于缓解与癌症相关的症状，但在日常实践中很少对其进行监测。我们旨在通过在手持式计算机上安装实时症状和综合征评估 E-MOSAIC 软件来测试使用该软件的效果，该软件生成纵向监测表（LoMoS）并提供给肿瘤学家，这是一项在 III 期设置中的研究。
在这项前瞻性、多中心、集群随机 III 期试验中，符合条件的患者为患有任何不可治愈的实体瘤且有明确的癌症相关症状、接受姑息性新门诊化疗（预期肿瘤大小反应率≤20%）的患者。在每周一次去肿瘤医生处就诊之前，所有患者都在护士的协助下完成 E-MOSAIC 评估：埃德蒙顿症状评估量表、≤3 个附加症状、估计营养摄入量、体重、卡诺夫斯基和用于疼痛和恶病质的药物。经验丰富的肿瘤学家将被随机分为接受或不接受 LoMoS。为了尽量减少污染，在就诊后将 LoMoS 从病历中取出。主要终点是在第 6 周的最后一次研究就诊时，与基线相比全球生活质量（EORTC-QlQ-C30 的第 29 和 30 项）的差异，手臂间 10 分的差异被认为具有临床意义。每治疗组有 20 个群组（=肿瘤学家），每个群组有 4-8 名患者，采用混合模型方法，达到 5%的显著性水平和 80%的功效。选择协变量包括在模型中进行调整。次要终点包括患者随时间推移感知的患者-医生沟通症状负担，以及肿瘤学家的症状管理表现（与肿瘤学家的药物治疗、诊断或咨询措施相比的症状预设阈值[结构化图表审查]）。
这项试验将有助于解决研究问题，即结构化、纵向监测患者的多维症状、症状管理指标和临床获益结果是否会影响患者的生活质量和症状困扰，在常规肿瘤学实践中。
当前对照试验 NCT00477919。
