Collection of Patient-Reported Symptoms and Performance Status Via the Internet
NCT ID: NCT00417040
Last Updated: 2017-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
325 participants
INTERVENTIONAL
2006-12-31
2017-06-01
Brief Summary
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Detailed Description
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PRIMARY OBJECTIVES:
I. To assess the feasibility of collecting symptom data directly from patients at clinic visits via waiting-area computers.
II. To preliminarily assess the level of agreement between patient and clinician Common Terminology Criteria for Adverse Events (CTCAE) symptom severity scoring, and to measure whether their scores converge when clinicians are exposed to patient self-reports.
OUTLINE:
Patients are registered into the Symptom Tracking and Reporting (STAR) database, obtain a password, undergo STAR training, and complete a patient-STAR questionnaire after seeing their clinician (baseline self-report) on day 1 of course 2\* of chemotherapy. Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3, 4, 5, and 6\* of chemotherapy. Clinicians review these patient reports before creating their own assessment. Patients also complete a patient feedback survey on day 1 of course 4\* of chemotherapy. Clinicians complete feedback survey at study completion.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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(Internet-based STAR database)
Patients are registered into the STAR database, obtain a password, undergo STAR training, and complete a patient-STAR questionnaire after seeing their clinician (baseline self-report) on day 1 of course 2\* of chemotherapy. Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3, 4, 5, and 6\* of chemotherapy. Clinicians review these patient reports before creating their own assessment. Patients also complete a patient feedback survey on day 1 of course 4\* of chemotherapy. Clinicians complete feedback survey at study completion.
NOTE: \*All time points are based on scheduled therapy with clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-70604, CALGB-80405, or CALGB-40503.
internet-based intervention
Use the STAR database system
assessment of therapy complications
Use the STAR database system
Questionnaire Administration
Ancillary studies
Interventions
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internet-based intervention
Use the STAR database system
assessment of therapy complications
Use the STAR database system
Questionnaire Administration
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* Enrolled on clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-40503, CALGB-70604, or CALGB-80405
PATIENT CHARACTERISTICS:
* Able to read and comprehend English language text
* Able to see a computer screen (i.e., no visual impairments) or be accompanied at visits by someone who can read the screen for the patient
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Ethan Basch, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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East Bay Radiation Oncology Center
Castro Valley, California, United States
Valley Medical Oncology Consultants - Castro Valley
Castro Valley, California, United States
Valley Medical Oncology
Fremont, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
El Camino Hospital Cancer Center
Mountain View, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Breast Surgeons, Incorporated
Oakland, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Larry G Strieff MD Medical Corporation
Oakland, California, United States
Tom K Lee, Incorporated
Oakland, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
La Grange Memorial Hospital
La Grange, Illinois, United States
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Veterans Affairs Medical Center - Iowa City
Iowa City, Iowa, United States
Menorah Medical Center
Overland Park, Kansas, United States
Saint Luke's Hospital - South
Overland Park, Kansas, United States
CCOP - Kansas City
Prairie Village, Kansas, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Michiana Hematology Oncology PC - Niles
Niles, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States
St. Joseph Medical Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Parvin Radiation Oncology
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Hospital
Liberty, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Comprehensive Cancer Care, PC
St Louis, Missouri, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Lakes Region General Hospital
Laconia, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Norris Cotton Cancer Center at Catholic Medical Center
Manchester, New Hampshire, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
Cancer Centers of the Carolinas - Easley
Easley, South Carolina, United States
Bon Secours St. Francis Health System
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, United States
Greenville Hospital Cancer Center
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Self Regional Cancer Center at Self Regional Medical Center
Greenwood, South Carolina, United States
Cancer Centers of the Carolinas - Greer Medical Oncology
Greer, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Countries
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Other Identifiers
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CDR0000521898
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2009-00489
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-70501
Identifier Type: -
Identifier Source: org_study_id
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