Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Electronic Tool to Record Cancer Symptoms in Patients With Advanced Cancer Receiving Palliative Care

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

Objectives

Primary

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) of patients with advanced incurable cancer receiving palliative anticancer treatment.

Secondary

1. Determine if this tool affects communication between these patients and their treating physicians.
2. Determine if this tool affects the symptoms and syndromes reported by these patients.
3. Determine if this tool impacts symptom management performance.

Tertiary

1. Identify factors influencing changes in G-QOL.
2. Determine how patients adapt to illness and burden of treatment.
3. Describe patients' decision-making preference.

Entry 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)

Prior/Concurrent Therapy:

• See Disease Characteristics
• No concurrent participation in another clinical trial

Patient Characteristics:

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

Expected Enrollment

A total of 24 physicians and 192 patients will be accrued for this study.

Outcomes

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

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

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).

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