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Conditions

Keywords

stage IV melanomastage IV renal cell cancerunresectable extrahepatic bile duct canceradvanced malignant mesotheliomastage IV prostate canceradult giant cell glioblastomaadult gliosarcomaextensive stage small cell lung cancerstage IV non-small cell lung cancerstage IV colon cancerstage IV gastric cancerstage IV esophageal cancerstage IV bladder cancermale breast cancerstage IV breast cancerstage IV ovarian epithelial cancerstage IV ovarian germ cell tumorovarian sarcomaovarian stromal cancerfatigueanorexiacachexiapainweight changesdepressionpoor performance statusrecurrent adult brain tumorclear cell sarcoma of the kidneyadvanced adult primary liver cancerrecurrent adult primary liver cancerrecurrent small cell lung cancerrecurrent bladder cancerrecurrent breast cancerrecurrent colon cancerrecurrent esophageal cancerrecurrent gastric cancerrecurrent melanomarecurrent non-small cell lung cancerrecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorstage IV pancreatic cancerrecurrent prostate cancerrecurrent renal cell cancerrecurrent pancreatic cancerstage IV rectal cancerrecurrent rectal cancerrecurrent malignant mesotheliomarecurrent carcinoma of unknown primarystage IV adult soft tissue sarcomarecurrent adult soft tissue sarcomastage IV uterine sarcomarecurrent uterine sarcomarecurrent extrahepatic bile duct cancerunresectable gallbladder cancerrecurrent gallbladder canceradult glioblastoma

Outcome Measures

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)
Until trial ends

Secondary Outcomes (3)

Determine if this tool affects communication between these patients and their treating physicians.
Until trial ends
Determine if this tool affects the symptoms and syndromes reported by these patients
Until trial ends

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

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

Study Sites (7)

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Inselspital Bern

Bern, CH-3010, Switzerland

Spital Buelach

Bülach, CH-8180, Switzerland

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Kantonsspital Freiburg

Fribourg, 1708, Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Related Publications (2)

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.

PMID: 23006802RESULT

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.

PMID: 26646758RESULT

E-MOSAIC Electronic Tool to Monitor Symptoms

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Weekly assessment by E-MOSAIC

Palm-based monitoring tool

Eligibility Criteria

Sponsors & Collaborators

Study Sites (7)

Related Publications (2)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

Condition Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Weekly assessment by E-MOSAIC

Palm-based monitoring tool

Eligibility Criteria

Sponsors & Collaborators

Study Sites (7)

Related Publications (2)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

Condition Hierarchy (Ancestors)

Source record

Locations