E-MOSAIC Electronic Tool to Monitor Symptoms

NCT ID: NCT00477919

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 264 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2012-01-31

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.

Conditions

Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florian Strasser, MD, ABHPM

Role: STUDY_CHAIR

Cantonal Hospital of St. Gallen

Locations

Universitaetsspital-Basel

Basel, , Switzerland

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Bellinzona, , Switzerland

Inselspital Bern

Bern, , Switzerland

Spital Buelach

Bülach, , Switzerland

Kantonsspital Graubuenden

Chur, , Switzerland

Kantonsspital Freiburg

Fribourg, , Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 23006802 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26646758 (View on PubMed)

Other Identifiers

EU-20711

Identifier Type: -

Identifier Source: secondary_id

SAKK 95/06

Identifier Type: -

Identifier Source: org_study_id