Abstract
BackgroundIn 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.MethodsIn 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]).DiscussionThis 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.Trial registrationCurrent Controlled Trials NCT00477919
Highlights
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
This study evaluates the effects of the E-MOSAIC intervention, a handheld computer-based assessment of patients’ symptoms, clinical benefit parameters and symptom management information, delivered real-time by the longitudinal monitoring sheet (LoMoS) to oncologists treating patients with anticancer treatment for advanced cancer in palliative intention
This study investigates the effect of E-MOSAIC delivered to oncologists on patient outcomes during a 6 week treatment duration applying a cluster-randomized controlled design
Summary
Incurable cancer, anticancer treatment may be used to alleviate cancer-related symptoms, but monitoring of them in daily practice is rarely done. Incurable cancer, anticancer treatment may alleviate patients’ cancer-related symptoms and cancer-associated complications [1]. These beneficial effects may occur even in the absence of a tumor response [2]. While both monitoring of tumor response and toxicity are defined by gold standards (i.e., RECIST, CTCAE v3.0), symptoms and syndromes, conceptualized as patient-reported outcomes (PROs), are yet only partially incorporated in routine oncology care [9,10]. Cachexia for instance is the combination of the sign weight loss and the symptom anorexia [12]
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