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...

Date First Received: May 23, 2007

Last Updated: December 25, 2007

Verified by: National Cancer Institute (NCI), October 2007

Clinical Trial Phase: Phase 3 Start Date: February 2007

Overall Status: Recruiting

Estimated Enrollment: 192

Brief Summary

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”

Condition Keyword(s):

• Cancer

Intervention(s):

• Procedure: cognitive assessment


• Procedure: counseling


• Procedure: fatigue assessment and management


• Procedure: psychosocial assessment and care


• Procedure: quality-of-life assessment

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.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Active Control

Detailed Clinical Trial 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.

Outcome Measures for this Clinical Trial

Primary:

• Change in global quality of life (G-QOL) as measured at baseline and after study completion

Secondary:

• G-QOL after study completion


• Communication as measured by patients' estimation of physicians' compassion and attribute and physicians' satisfaction with patient-physician communication


• 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


• 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


• 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)


• Change in burden of illness and treatment over time


• Comparison of the number of mismatched decision-making preferences between weeks 3-6

Criteria for Participation in this Clinical Trial

DISEASE CHARACTERISTICS:

• Diagnosis of advanced incurable cancer


• Symptomatic disease, defined as meeting ≥ 1 of the following criteria:


• Pain Visual Analogue Scale (VAS) ≥ 3/10 and/or morphine equivalent daily dose of ≥ 10 mg for ≥ 3 days


• Anorexia VAS ≥ 3/10 and/or weight loss of ≥ 2% in 2 months or ≥ 5% in 6 months


• Fatigue VAS ≥ 3/10 and/or Karnofsky performance status greater than 70%


• Depression or anxiety VAS ≥ 3/10 and/or treatment with antidepressants for ≥ 5 days and planned for ≥ 1 month


• Receiving continuously, weekly, or biweekly palliative anticancer treatment meeting 1 of the following criteria:


• At least 1 first-line treatment for any of the following:


• Metastatic melanoma


• Renal cell cancer


• Pancreatic cancer


• Biliary tract cancer


• Mesothelioma


• Prostate cancer (chemotherapy)


• Advanced glioblastoma


• At least 1 second-line treatment for any of the following:


• Extensive stage small cell lung cancer


• Stage IV non-small cell lung cancer


• Colorectal cancer


• Gastric cancer


• Esophageal cancer


• Bladder cancer


• Sarcoma


• Carcinoma of unknown primary


• At least 1 third-line chemotherapy regimen for any of the following:


• Metastatic breast cancer


• Ovarian cancer


• Anticancer treatment must be given in an outpatient setting, not within a clinical trial, with weekly monitoring, and expected tumor response rate ≤ 20% according to the literature


• No testicular cancer


• No hematological malignancies


• No primary brain tumors other than glioblastoma


• Physician characteristics:


• No change to standard of care for symptom assessment or to major communication skills strategies within the past 3 months


• Experienced in medical oncology (i.e., worked ≥ 50% in clinical oncology within the past 24 months)


• Likely to stay in the participating institution for the time required to treat ≥ 5 study patients


• Able to independently communicate with the patient about all aspects of cancer care


• Able to independently perform immediate changes of interventions in patient care without the institutional requirement to counsel another colleague before prescribing (i.e., for symptom control)


• Completed a basic communication skills course or equivalent training (i.e., familiar with communication skills)

PATIENT CHARACTERISTICS:

• Able to understand assessment instrument language


• Able to understand physician communication without difficulty (i.e., due to culture, language, speech)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics


• No concurrent participation in another clinical trial

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Swiss Group for Clinical Cancer Research

Kantonsspital - St. Gallen

St. Gallen CH-9007 Switzerland

Overall Clinical Trial Officials and Contacts

Florian Strasser, MD Study Chair Kantonsspital - St. Gallen

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00477919

Study ID Number: CDR0000536483

ClinicalTrials.gov Identifier: NCT00477919

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

Labels: ClinicalTrial