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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000521898 | Registry Identifier | NCI Physician Data Query | |
| NCI-2009-00489 | Registry Identifier | NCI Clinical Trial Reporting Program | |
| UG1CA189823 | U.S. NIH Grant/Contract | View source | |
| U10CA037447 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Internet-based STAR database) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| internet-based intervention | Other | Use the STAR database system |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ethan Basch, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Bay Radiation Oncology Center | Castro Valley | California | 94546 | United States | ||
| Valley Medical Oncology Consultants - Castro Valley |
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| assessment of therapy complications |
| Other |
Use the STAR database system |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| At baseline (day 22) |
| Mean severity scores for patient reporting at day 43 | Up to day 43 |
| Castro Valley |
| California |
| 94546 |
| United States |
| Valley Medical Oncology | Fremont | California | 94538 | United States |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | United States |
| El Camino Hospital Cancer Center | Mountain View | California | 94040 | United States |
| Highland General Hospital | Oakland | California | 94602 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| Bay Area Breast Surgeons, Incorporated | Oakland | California | 94609 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Larry G Strieff MD Medical Corporation | Oakland | California | 94609 | United States |
| Tom K Lee, Incorporated | Oakland | California | 94609 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Doctors Medical Center - San Pablo Campus | San Pablo | California | 94806 | United States |
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803-1273 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Louis A. Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| La Grange Memorial Hospital | La Grange | Illinois | 60525 | United States |
| Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford | Illinois | 61108 | United States |
| Elkhart Clinic, LLC | Elkhart | Indiana | 46514-2098 | United States |
| Michiana Hematology-Oncology, PC - Elkhart | Elkhart | Indiana | 46514 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| Michiana Hematology-Oncology, PC - South Bend | Mishawaka | Indiana | 46545-1470 | United States |
| Saint Joseph Regional Medical Center | Mishawaka | Indiana | 46545-1470 | United States |
| Michiana Hematology Oncology PC - Plymouth | Plymouth | Indiana | 46563 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Michiana Hematology Oncology PC - La Porte | Westville | Indiana | 46391 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Veterans Affairs Medical Center - Iowa City | Iowa City | Iowa | 52246 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| Saint Luke's Hospital - South | Overland Park | Kansas | 66213 | United States |
| CCOP - Kansas City | Prairie Village | Kansas | 66208 | United States |
| CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Union Hospital of Cecil County | Elkton | Maryland | 21921 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts | 02115 | United States |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Michiana Hematology Oncology PC - Niles | Niles | Michigan | 49120 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan | 49085 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Goldschmidt Cancer Center | Jefferson City | Missouri | 65109 | United States |
| Truman Medical Center - Hospital Hill | Kansas City | Missouri | 64108 | United States |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| St. Joseph Medical Center | Kansas City | Missouri | 64114 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| Parvin Radiation Oncology | Kansas City | Missouri | 64116 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | 64086 | United States |
| Liberty Hospital | Liberty | Missouri | 64068 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| Comprehensive Cancer Care, PC | St Louis | Missouri | 63141 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire | 03301 | United States |
| New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Lakes Region General Hospital | Laconia | New Hampshire | 03246 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Norris Cotton Cancer Center at Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| Elmhurst Hospital Center | Elmhurst | New York | 11373 | United States |
| Queens Cancer Center of Queens Hospital | Jamaica | New York | 11432 | United States |
| Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York | 11042 | United States |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Veterans Affairs Medical Center - Syracuse | Syracuse | New York | 13210 | United States |
| Mission Hospitals - Memorial Campus | Asheville | North Carolina | 28801 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst | North Carolina | 28374 | United States |
| Iredell Memorial Hospital | Statesville | North Carolina | 28677 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | 02903 | United States |
| Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Cancer Centers of the Carolinas - Easley | Easley | South Carolina | 29640 | United States |
| Bon Secours St. Francis Health System | Greenville | South Carolina | 29601 | United States |
| Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina | 29605 | United States |
| Cancer Centers of the Carolinas - Grove Commons | Greenville | South Carolina | 29605 | United States |
| Greenville Hospital Cancer Center | Greenville | South Carolina | 29605 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| Self Regional Cancer Center at Self Regional Medical Center | Greenwood | South Carolina | 29646 | United States |
| Cancer Centers of the Carolinas - Greer Medical Oncology | Greer | South Carolina | 29650 | United States |
| Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina | 29672 | United States |
| Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| Mountainview Medical | Berlin Corners | Vermont | 05602 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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