E-MOSAIC: A multicentre randomised controlled trial of longitudinal electronic monitoring of symptoms and syndromes associated with advanced cancer in patients treated with chemotherapy in palliative intention

Projekt

E-MOSAIC: A multicentre randomised controlled trial of longitudinal electronic monitoring of symptoms and syndromes associated with advanced cancer in patients treated with chemotherapy in palliative intention

Abgeschlossen · 2007 bis 2012

Linder Susanne, Blum David, Kehl Jeanine, Strasser Florian

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Bereiche

Medizinische Onkologie und Hämatologie, Zentrum für Integrative Medizin

Status

Abgeschlossen

Start

2007

Ende

2012

Finanzierungsart

Andere

Studiendesign

Study Type: Interventional Study Design: Allocation: Randomized Primary Purpose: Health Services Research Further study details as provided by National Cancer Institute (NCI): Primary Outcome Measures: •Change in global quality of life (G-QOL) as measured at baseline and after study completion [ Designated as safety issue: No ] Secondary Outcome Measures: •G-QOL after study completion [ Designated as safety issue: No ] •Communication as measured by patients' estimation of physicians' compassion and attribute and physicians' satisfaction with patient-physician communication [ Designated as safety issue: No ] •Change in symptoms and syndromes as measured by difference in Edmonton Symptom Assessment Scale Score, Karnofsky performance status, weight, shortness of breath, nutritional intake, and 3 patient chosen symptoms at baseline and after study completion [ Designated as safety issue: No ] •Symptom management performance as measured by number of visits with a symptom load above a defined threshold of 5 symptoms without immediate intervention and number of accompanying persons in weeks 3-6 [ Designated as safety issue: No ] •Factors influencing the change in G-QOL (i.e., tumor response [complete and partial response, stable or progressive disease], tumor type, predominant symptom, anxiety, complexity, education, hospitalization) [ Designated as safety issue: No ] •Change in burden of illness and treatment over time [ Designated as safety issue: No ] •Comparison of the number of mismatched decision-making preferences between weeks 3-6 [ Designated as safety issue: No ]

Kurzbeschreibung/Zielsetzung

RATIONALE: A hand held electronic tool used to monitor symptoms and assess quality of life may improve communication between patients and their doctors and improve the ability to plan treatment for patients with advanced cancer receiving palliative care. It is not yet known whether symptoms are better controlled with or without use of this electronic tool.

PURPOSE: This randomized phase III trial is studying an electronic tool to see how well it records cancer symptoms in patients with advanced cancer receiving palliative care.

OBJECTIVES:

Primary

•Determine the effect of an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC) and a Longitudinal Monitoring Sheet (LoMoS) on global quality of life (G-QOL) of patients with advanced incurable cancer receiving palliative anticancer treatment.
Secondary

•Determine if this tool affects communication between these patients and their treating physicians.
•Determine if this tool affects the symptoms and syndromes reported by these patients.
•Determine if this tool impacts symptom management performance.
Tertiary

•Identify factors influencing changes in G-QOL.
•Determine how patients adapt to illness and burden of treatment.
•Describe patients' decision-making preference.
OUTLINE: This is a controlled, randomized, longitudinal, multicenter study. Physicians are stratified according to participating center. Physicians are randomized to 1 of 2 arms. All patients allocated to a physician undergo the same intervention.

•Arm I: Patients complete a weekly symptom assessment and nutritional intake using a Palm-based monitoring tool. Nurses record weight and Karnofsky performance status (KPS) scores weekly. A proof of electronic transfer sheet is printed and stored.
•Arm II: Patients complete a weekly assessment comprising visual analogue scales (VAS) of pain, fatigue, drowsiness, nausea, anxiety, depression, shortness of breath, loss of appetite, and overall well-being; up to 3 optional symptoms selected by the patient; and an estimated nutritional intake using an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC). Nurses record the patient's weight, KPS score, body mass index, and assessment of current medication for pain (i.e., morphine-equivalent daily dose), fatigue, and anorexia/cachexia syndromes weekly. A Longitudinal Monitoring Sheet (LoMoS) is printed (comprising VAS of pain, pain medication, fatigue, KPS, medication for fatigue [i.e., methylphenidate hydrochloride or epoetin alfa], anorexia, weight change, nutritional intake, medication, supplements, counseling for anorexia, VAS of individually selected symptoms) and stored.
In both arms, patients are assessed for outcome criteria at baseline and at weeks 3 and 6 (end of study).