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CancerNCT00477919

E-MOSAIC Electronic Tool to Monitor Symptoms

An observational study of Cancer, run by Swiss Cancer Institute at 7 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
How many people
264 participants
Where
7 sitesSwitzerland
Study dates
Feb 2007to Jan 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with advanced incurable cancer

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Switzerland7 sites

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

    Bellinzona, CH-6500

  • Inselspital Bern

    Bern, CH-3010

  • Spital Buelach

    Bülach, CH-8180

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Kantonsspital Freiburg

    Fribourg, 1708

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

About this study

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

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.

Read the 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.

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
Medical subject headings
Neoplasms, Melanoma, Carcinoma, Renal Cell, Prostatic Neoplasms, Glioblastoma, Gliosarcoma, Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00477919
Study groupRoleWhat they receive
Weekly assessment by E-MOSAICPatients 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 toolPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Until trial ends

Secondary outcomes (3)

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

    Measured: Until trial ends

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

    Measured: Until trial ends

  3. Determine if this tool impacts symptom management performance

    Measured: Until trial ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00477919
Sponsor's protocol ID
SAKK 95/06
Other IDs
EU-20711
Status last verified
May 2019
First submitted
23 May 2007
Last updated
15 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23006802

  • 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.

    PubMed 26646758

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Swiss Cancer Institute at 7 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Until trial ends). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00477919, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.

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