Clinical trial NCT00477919: E-MOSAIC Electronic Tool to Monitor Symptoms
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: 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
recurrent small cell lung cancer
recurrent bladder cancer
recurrent breast cancer
recurrent colon cancer
recurrent esophageal cancer
recurrent gastric cancer
recurrent melanoma
recurrent non-small cell lung cancer
recurrent ovarian epithelial cancer
recurrent ovarian germ cell tumor
stage IV pancreatic cancer
recurrent prostate cancer
recurrent renal cell cancer
recurrent pancreatic cancer
stage IV rectal cancer
recurrent rectal cancer
recurrent malignant mesothelioma
recurrent carcinoma of unknown primary
stage IV adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
recurrent extrahepatic bile duct cancer
unresectable gallbladder cancer
recurrent gallbladder cancer
adult glioblastoma
Lead sponsor: Swiss Group for Clinical Cancer Research
Sponsor class: OTHER
First posted: 2007-05-24
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced incurable cancer

Brief summary: 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.

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 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

Primary outcomes:
measure: 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)
timeFrame: Until trial ends
Secondary outcomes:
measure: Determine if this tool affects communication between these patients and their treating physicians.
timeFrame: Until trial ends
measure: Determine if this tool affects the symptoms and syndromes reported by these patients
timeFrame: Until trial ends
measure: Determine if this tool impacts symptom management performance
timeFrame: Until trial ends
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitaetsspital-Basel
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Bulach
country: Switzerland
facility: Spital Buelach
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
city: Freiburg
country: Switzerland
facility: Kantonsspital Freiburg
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
Study officials:
affiliation: Cantonal Hospital of St. Gallen
name: Florian Strasser, MD, ABHPM
role: STUDY_CHAIR
References:
citation: Blum D, Koeberle D, Ribi K, Schmitz SF, Utiger U, Klingbiel D, Strasser F. Electronic monitoring of symptoms and syndromes associated with cancer: methods of a randomized controlled trial SAKK 95/06 E-MOSAIC. BMC Palliat Care. 2012 Sep 24;11:19. doi: 10.1186/1472-684X-11-19.
citation: Strasser F, Blum D, von Moos R, Cathomas R, Ribi K, Aebi S, Betticher D, Hayoz S, Klingbiel D, Brauchli P, Haefner M, Mauri S, Kaasa S, Koeberle D; Swiss Group for Clinical Cancer Research (SAKK). The effect of real-time electronic monitoring of patient-reported symptoms and clinical syndromes in outpatient workflow of medical oncologists: E-MOSAIC, a multicenter cluster-randomized phase III study (SAKK 95/06). Ann Oncol. 2016 Feb;27(2):324-32. doi: 10.1093/annonc/mdv576. Epub 2015 Dec 8.