Collection of Patient-Reported Symptoms and Performance Status Via the Internet
- Conditions
- Breast CancerColorectal CancerMultiple MyelomaProstate CancerLung CancerLeukemia
- Interventions
- Other: internet-based interventionOther: assessment of therapy complicationsOther: Questionnaire Administration
- Registration Number
- NCT00417040
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This pilot clinical trial studies how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting room computer to report their symptoms and their ability to carry out daily activities may help doctors understand a patient's use of a computer to report symptoms.
- Detailed Description
This study enrolled participants who were diagnosed with breast cancer, lung cancer, colorectal cancer, leukemia and multiple myeloma and prostate cancer.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description (Internet-based STAR database) assessment of therapy complications 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 STAR database) internet-based intervention 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 STAR database) Questionnaire Administration 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.
- Primary Outcome Measures
Name Time Method Willingness of approached patients to participate in this study this study Up to 6 years Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit any given follow-up visit Up to 16 weeks Proportion of total attended visits during the study period at which a questionnaire was completed (completers:visits) which a questionnaire was completed (completers:visits) Up to 15 weeks
- Secondary Outcome Measures
Name Time Method Patient-reported CTCAE symptoms using symptom severity data At baseline (day 22) Clinician-reported CTCAE symptoms using symptom severity data clinician reporting at day 43 (when patients report before clinicians; clinicians view those reports) vs at day 22 (patients report symptoms after the clinical encounter) At baseline (day 22) Mean severity scores for patient reporting at day 43 Up to day 43
Trial Locations
- Locations (95)
El Camino Hospital Cancer Center
🇺🇸Mountain View, California, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
Cancer Centers of the Carolinas - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, 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
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Michiana Hematology-Oncology, PC - South Bend
🇺🇸Mishawaka, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
🇺🇸Plymouth, Indiana, United States
Michiana Hematology Oncology PC - La Porte
🇺🇸Westville, Indiana, 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
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Saint Luke's Hospital - South
🇺🇸Overland Park, Kansas, United States
Union Hospital of Cecil County
🇺🇸Elkton, Maryland, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Bon Secours St. Francis Health System
🇺🇸Greenville, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Mountainview Medical
🇺🇸Berlin Corners, Vermont, United States
Michiana Hematology Oncology PC - Niles
🇺🇸Niles, Michigan, United States
CancerCare of Maine at Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Lakeside Cancer Specialists, PLLC
🇺🇸Saint Joseph, Michigan, United States
Cancer Centers of the Carolinas - Grove Commons
🇺🇸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
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
Valley Medical Oncology
🇺🇸Fremont, California, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
Highland General Hospital
🇺🇸Oakland, California, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, 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
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸Mishawaka, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
CCOP - Kansas City
🇺🇸Prairie Village, Kansas, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Lakes Region General Hospital
🇺🇸Laconia, New Hampshire, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
Norris Cotton Cancer Center at Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Monter Cancer Center of the North Shore-LIJ Health System
🇺🇸Lake Success, New York, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, 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
Rhode Island Hospital Comprehensive Cancer Center
🇺🇸Providence, Rhode Island, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Cancer Centers of the Carolinas - Easley
🇺🇸Easley, South Carolina, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Cancer Centers of the Carolinas - Seneca
🇺🇸Seneca, South 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
Cancer Centers of the Carolinas - Faris Road
🇺🇸Greenville, South Carolina, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, 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
North Kansas City Hospital
🇺🇸Kansas City, Missouri, United States
St. Joseph Medical Center
🇺🇸Kansas City, Missouri, United States
Parvin Radiation Oncology
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Tom K Lee, Incorporated
🇺🇸Oakland, California, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
La Grange Memorial Hospital
🇺🇸La Grange, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Southeast Cancer Center
🇺🇸Cape Girardeau, Missouri, United States
Goldschmidt Cancer Center
🇺🇸Jefferson City, Missouri, United States
Liberty Hospital
🇺🇸Liberty, Missouri, United States
Saint Luke's East - Lee's Summit
🇺🇸Lee's Summit, Missouri, United States
Comprehensive Cancer Care, PC
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Bay Area Breast Surgeons, Incorporated
🇺🇸Oakland, California, United States
Larry G Strieff MD Medical Corporation
🇺🇸Oakland, California, United States
Veterans Affairs Medical Center - Iowa City
🇺🇸Iowa City, Iowa, United States
Greenville Hospital Cancer Center
🇺🇸Greenville, South Carolina, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, 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