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NCT Number: NCT00477919

E-MOSAIC Electronic Tool to Monitor Symptoms

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.

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Key information

Conditions

Cancer Adenocarcinoma Adenoma Adnexal Diseases Anorexia Astrocytoma Behavior Behavioral Symptoms Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Body Weight Body Weight Changes Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Cachexia Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Renal Cell Central Nervous System Diseases Central Nervous System Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Depression Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioblastoma Glioma Gliosarcoma Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Mesothelioma Mesothelioma, Malignant Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Unknown Primary Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pain Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Neoplasms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Stomach Diseases Stomach Neoplasms Thinness Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsspital-Basel, Basel, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Determine if this tool affects communication between these patients and their treating physicians.

    Time frame: Until trial ends

  2. Determine if this tool affects the symptoms and syndromes reported by these patients

    Time frame: Until trial ends

  3. Determine if this tool impacts symptom management performance

    Time frame: Until trial ends

Sponsors and collaborators

Lead sponsor

Swiss Cancer Institute

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
May 24, 2007
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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