Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

E-MOSAIC Electronic Tool to Monitor Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00477919
First received: May 23, 2007
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Phase
Cancer
Phase 3

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine if this tool affects communication between these patients and their treating physicians. [ Time Frame: Until trial ends ] [ Designated as safety issue: No ]
  • Determine if this tool affects the symptoms and syndromes reported by these patients [ Time Frame: Until trial ends ] [ Designated as safety issue: No ]
  • Determine if this tool impacts symptom management performance [ Time Frame: Until trial ends ] [ Designated as safety issue: No ]

Enrollment: 264
Study Start Date: February 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with advanced incurable cancer

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477919

Locations
Switzerland
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
Inselspital Bern
Bern, Switzerland, CH-3010
Spital Buelach
Bulach, Switzerland, CH-8180
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Kantonsspital Freiburg
Freiburg, Switzerland, 1708
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Florian Strasser, MD, ABHPM Cantonal Hospital of St. Gallen
  More Information

Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00477919     History of Changes
Other Study ID Numbers: SAKK 95/06, EU-20711
Study First Received: May 23, 2007
Last Updated: December 10, 2013
Health Authority: Switzerland: Ethical Committee

Keywords provided by Swiss Group for Clinical Cancer Research:
stage IV melanoma
stage IV renal cell cancer
unresectable extrahepatic bile duct cancer
advanced malignant mesothelioma
stage IV prostate cancer
adult giant cell glioblastoma
adult gliosarcoma
extensive stage small cell lung cancer
stage IV non-small cell lung cancer
stage IV colon cancer
stage IV gastric cancer
stage IV esophageal cancer
stage IV bladder cancer
male breast cancer
stage IV breast cancer
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
ovarian sarcoma
ovarian stromal cancer
fatigue
anorexia
cachexia
pain
weight changes
depression
poor performance status
recurrent adult brain tumor
clear cell sarcoma of the kidney
advanced adult primary liver cancer
recurrent adult primary liver cancer

ClinicalTrials.gov processed this record on November 27, 2014