E-MOSAIC Electronic Tool to Monitor Symptoms

Completed

• Conditions: Cancer

• Registration Number: NCT00477919
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

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.

Detailed Description

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).

PROJECTED ACCRUAL: A total of 24 physicians and 192 patients will be accrued for this study.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	Until trial ends

Secondary Outcome Measures

Name	Time	Method
Determine if this tool affects the symptoms and syndromes reported by these patients	Until trial ends
Determine if this tool affects communication between these patients and their treating physicians.	Until trial ends
Determine if this tool impacts symptom management performance	Until trial ends

Trial Locations

Locations (7)

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

Spital Buelach; 🇨🇭 Bulach, Switzerland

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni; 🇨🇭 Bellinzona, Switzerland

Kantonsspital Freiburg; 🇨🇭 Freiburg, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland