E-MOSAIC Electronic Tool to Monitor Symptoms

NCT00477919 | Completed DMC

• 2 other identifiers: SAKK 95/06EU-20711
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 7

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.

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

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

• Determine if this tool impacts symptom management performance

  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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (7)

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Spital Buelach

Bülach, CH-8180, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Kantonsspital Freiburg

Fribourg, 1708, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

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: 23006802 RESULT

• 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: 26646758 RESULT

MeSH Terms

Conditions

Neoplasms; Melanoma; Carcinoma, Renal Cell; Prostatic Neoplasms; Glioblastoma; Gliosarcoma; Carcinoma, Non-Small-Cell Lung; Colonic Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Urinary Bladder Neoplasms; Breast Neoplasms, Male; Breast Neoplasms; Carcinoma, Ovarian Epithelial; Fatigue; Anorexia; Cachexia; Pain; Body Weight Changes; Depression; Brain Neoplasms; Carcinoma, Hepatocellular; Small Cell Lung Carcinoma; Pancreatic Neoplasms; Rectal Neoplasms; Mesothelioma, Malignant; Neoplasms, Unknown Primary; Sarcoma; Bile Duct Neoplasms; Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Urinary Bladder Diseases; Breast Diseases; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Weight Loss; Body Weight; Thinness; Neurologic Manifestations; Behavioral Symptoms; Behavior; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Neoplasms; Liver Diseases; Pancreatic Diseases; Rectal Diseases; Mesothelioma; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Neoplasms, Connective and Soft Tissue; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Gallbladder Diseases

Study Officials

• Florian Strasser, MD, ABHPM

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 24, 2007
• Study Start: February 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

CH (7)