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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00477919 |
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.
Condition | Intervention | Phase |
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Cancer |
Other: counseling intervention Procedure: cognitive assessment Procedure: fatigue assessment and management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Phase III |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Active Control |
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 |
Estimated Enrollment: | 192 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
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.
PROJECTED ACCRUAL: A total of 24 physicians and 192 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Symptomatic disease, defined as meeting ≥ 1 of the following criteria:
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:
At least 1 second-line treatment for any of the following:
At least 1 third-line chemotherapy regimen for any of the following:
Physician characteristics:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Switzerland | |
Kantonsspital - St. Gallen | Recruiting |
St. Gallen, Switzerland, CH-9007 | |
Contact: Florian Strasser, MD, ABHPM 41-71-494-1111 florian.strasser@kssg.ch |
Study Chair: | Florian Strasser, MD, ABHPM | Kantonsspital - St. Gallen |
Study ID Numbers: | CDR0000536483, SWS-SAKK-95/06, EU-20711, SWS-SAKK-E-MOSAIC |
Study First Received: | May 23, 2007 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00477919 History of Changes |
Health Authority: | Unspecified |
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 |
Glioblastoma Rectal Neoplasms Pancreatic Neoplasms Esophageal Neoplasms Cachexia Pain Breast Cancer, Male Bile Duct Cancer, Extrahepatic Melanoma Body Weight Liver Neoplasms Soft Tissue Sarcomas Renal Cancer Lung Neoplasms Stomach Neoplasms |
Body Weight Changes Bladder Neoplasm Kidney Cancer Depression Fatigue Rectal Neoplasm Urinary Bladder Neoplasms Breast Neoplasms Sarcoma, Clear Cell Esophageal Cancer Ovarian Epithelial Cancer Depressive Disorder Recurrence Carcinoma Carcinoma, Small Cell |