E-MOSAIC Electronic Tool to Monitor Symptoms

May 14, 2019 updated by: Swiss Group for Clinical Cancer Research

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

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, CH-4031
        • Universitaetsspital-Basel
      • Bellinzona, Switzerland, CH-6500
        • Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
      • Bern, Switzerland, CH-3010
        • Inselspital Bern
      • Bulach, Switzerland, CH-8180
        • Spital Buelach
      • Chur, Switzerland, CH-7000
        • Kantonsspital Graubuenden
      • Freiburg, Switzerland, 1708
        • Kantonsspital Freiburg
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with advanced incurable cancer

Description

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 < 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Weekly assessment by E-MOSAIC
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.
Palm-based monitoring tool
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: Until trial ends
Until trial ends

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Florian Strasser, MD, ABHPM, Cantonal Hospital of St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 23, 2007

First Submitted That Met QC Criteria

May 23, 2007

First Posted (Estimate)

May 24, 2007

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAKK 95/06
  • EU-20711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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