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Open Access Study protocol

Electronic monitoring of symptoms and syndromes associated with cancer: methods of a randomized controlled trial SAKK 95/06 E-MOSAIC

David Blum12, Dieter Koeberle3, Karin Ribi4, Shu-Fang Hsu Schmitz57, Urs Utiger6, Dirk Klingbiel5 and Florian Strasser1*

Author Affiliations

1 Oncological Palliative Medicine, Section Oncology, Department of Internal Medicine and Palliative Care Centre, Cantonal Hospital St. Gallen, Rorschacherstrasse 95, St. Gallen 9007, Switzerland

2 European Palliative Research Center; Dept. Cancer Research and Molecular Medicine, NTNU, Faculty of Medicine, Trondheim, Norway

3 Oncology, Dept. Internal Medicine and Palliative Centre, Cantonal Hospital St. Gallen, St. Gallen, Switzerland

4 IBCSG Coordinating Center, Quality of Life Office, Bern, Switzerland

5 Statistics Unit, SAKK Coordinating Center, Bern, Switzerland

6 Clinical Trial Management Unit, SAKK Coordinating Center, Bern, Switzerland

7 Current address: Institute of Mathematical Statistics and Actuarial Science, University of Bern, Bern, Switzerland

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BMC Palliative Care 2012, 11:19  doi:10.1186/1472-684X-11-19

Published: 24 September 2012

Abstract

Background

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-MO

    S
AIC software installed in handheld computer generating a longitudinal monitoring sheet (LoMoS) provided to the oncologists in a phase III setting.

Methods

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-MO

    S
AIC 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]).

Discussion

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.

Trial registration

Current Controlled Trials NCT00477919