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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of an Electronic Tool for Monitoring Symptoms and Syndromes Associated With Advanced Cancer (E-MOSAIC) in Patients With Advanced Incurable Cancer Receiving Palliative Anticancer Treatment

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Health services research Active 18 and over Other SWS-SAKK-95/06 SAKK-95/06, EU-20711, SWS-SAKK-E-MOSAIC, NCT00477919

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Advanced cancer causing pain, anorexia, weight loss, fatigue, depression, and/or anxiety
• No testicular cancer, hematologic cancer, or primary brain tumors (other than glioblastoma)
• Receiving palliative anticancer treatment continuously, every week, or every other week as an outpatient
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Doctors and their patients will be randomly assigned (have an equal chance of being placed) to one of two groups.

In group one, patients will use a hand held electronic tool once a week to record information about their symptoms and diet. Nurses will record the patient’s weight and Karnofsky performance status once a week. Information from the hand held electronic tool will be printed and stored.

In group two, patients will use a hand held electronic tool once a week to rate specific symptoms, including pain, fatigue, drowsiness, nausea, anxiety, depression, shortness of breath, loss of appetite, overall well-being, other symptoms, and diet. Nurses will record the patient’s weight, Karnofsky performance status, body mass index, and use of medications for pain, fatigue, anorexia, or weight loss once a week. Information from the hand held electronic tool will be printed and stored.

In both groups, patients will be evaluated at the beginning of the study and at 3 and 6 weeks.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Florian Strasser, MD, ABHPM, Protocol chair		Ph: 41-71-494-1111 Email: florian.strasser@kssg.ch

Switzerland
	St. Gallen
	Kantonsspital - St. Gallen
		Florian Strasser, MD, ABHPM	Ph:  41-71-494-1111
			Email: florian.strasser@kssg.ch

Registry Information
Official Title		E-MOSAIC: A Multicenter Randomized Controlled Phase III Study of Longitudinal Electronic Monitoring of Symptoms and Syndromes Associated with Advanced Cancer in Patients Receiving Anticancer Treatment in Palliative Intention
Trial Start Date		2007-02-20
Trial Completion Date		2010-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00477919
Date Submitted to PDQ		2007-02-12
Information Last Verified		2008-11-30