Patientrapporterede resultater hos langtidsoverlevere af tyktarms- og endetarmskræft
15. december 2010 opdateret af: NSABP Foundation Inc
Patientrapporterede resultater hos langtidsoverlevere med tyktarms- og endetarmskræft
RATIONALE: At lære om livskvalitet, symptomer og sundhedsadfærd hos overlevende af tyktarmskræft kan hjælpe med at bestemme de langsigtede virkninger af tyktarms- og endetarmskræftbehandlinger og kan hjælpe med at forbedre livskvaliteten for fremtidige kræftoverlevere.
FORMÅL: Dette kliniske forsøg ser på patientrapporterede resultater hos langtidsoverlevere af tyktarms- og endetarmskræft.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MÅL:
- Karakteriser 3 separate typer patientrapporterede resultater (livskvalitet [f.eks. generisk og sygdomsspecifik], funktionelle resultater [f.eks. tarm og seksuel funktion og dagligdags aktiviteter] og kliniske symptomer [f.eks. smerte, træthed]) hos langtidsoverlevere (5+ år) af tyktarms- og endetarmskræft i en stor national prøve rekrutteret fra fem National Surgical Adjuvant Breast and Bowel Project (NSABP) behandlingsforsøg.
- Udforsk i hvilken grad patientrapporterede resultater påvirkes af individuelle karakteristika (f.eks. specifikke prædisponerende faktorer, muliggørende ressourcer og behov), af sundhedsadfærd (f.eks. brug af tjenester til kræftrelaterede og ikke-kræftrelaterede problemer), og, når det er relevant, af de specifikke behandlinger, der blev modtaget.
- Undersøg patientrapporterede resultater før randomisering og behandling, 1 år efter behandling og i langtidsopfølgning > 5 år efter diagnose hos patienter med tyktarmskræft behandlet med adjuverende kemoterapi på protokollerne NSABP C-06 eller NSABP C-07.
OVERSIGT: Dette er en kohorte, enkelt-gruppe, multicenter undersøgelse.
Patienter gennemfører et engangs, computerassisteret telefoninterview, der vurderer deres overordnede livskvalitet (QOL), sygdomsspecifikke QOL, funktion og symptomer (herunder smerter og træthed), brug af sundhedsydelser, prævalens og sværhedsgrad af komorbiditet og demografi .
PROJEKTERET TILSLUTNING: I alt 1.167 patienter vil blive opsamlet til denne undersøgelse.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
744
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Forenede Stater, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Forenede Stater, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Forenede Stater, 80210
- Porter Adventist Hospital
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Denver, Colorado, Forenede Stater, 80220
- Rose Medical Center
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Forenede Stater, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Forenede Stater, 80218
- St. Joseph Hospital
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Denver, Colorado, Forenede Stater, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Forenede Stater, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Forenede Stater, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Forenede Stater, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Forenede Stater, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Forenede Stater, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Forenede Stater, 80539
- McKee Medical Center
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Pueblo, Colorado, Forenede Stater, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Forenede Stater, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Forenede Stater, 80033
- Exempla Lutheran Medical Center
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Delaware
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Lewes, Delaware, Forenede Stater, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Forenede Stater, 19713
- CCOP - Christiana Care Health Services
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Hospital
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Atlanta, Georgia, Forenede Stater, 30342-1611
- Northside Hospital Cancer Center
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Atlanta, Georgia, Forenede Stater, 30342-1701
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, Forenede Stater, 30342
- CCOP - Atlanta Regional
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Austell, Georgia, Forenede Stater, 30106
- WellStar Cobb Hospital
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Decatur, Georgia, Forenede Stater, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Lawrenceville, Georgia, Forenede Stater, 30045
- Gwinnett Medical Center
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Marietta, Georgia, Forenede Stater, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, Forenede Stater, 30274-2600
- Southern Regional Medical Center
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Savannah, Georgia, Forenede Stater, 31403-3089
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
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Illinois
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Alton, Illinois, Forenede Stater, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Aurora, Illinois, Forenede Stater, 60504
- Rush-Copley Cancer Care Center
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Decatur, Illinois, Forenede Stater, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Evanston, Illinois, Forenede Stater, 60201-1781
- Evanston Northwestern Healthcare - Evanston Hospital
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Joliet, Illinois, Forenede Stater, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Mt. Vernon, Illinois, Forenede Stater, 62864
- Good Samaritan Regional Health Center
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Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Indiana
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Elkhart, Indiana, Forenede Stater, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Forenede Stater, 46904
- Howard Community Hospital
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La Porte, Indiana, Forenede Stater, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Lafayette, Indiana, Forenede Stater, 47904
- Clarian Arnett Cancer Care
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Michigan City, Indiana, Forenede Stater, 46360
- Saint Anthony Memorial Health Centers
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Forenede Stater, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic, PC
-
Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Forenede Stater, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Forenede Stater, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Forenede Stater, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Forenede Stater, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, PA - El Dorado
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Independence, Kansas, Forenede Stater, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Forenede Stater, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Forenede Stater, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Forenede Stater, 67901
- Southwest Medical Center
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Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas, PA - Newton
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Overland Park, Kansas, Forenede Stater, 66209
- Menorah Medical Center
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Parsons, Kansas, Forenede Stater, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Forenede Stater, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, PA - Salina
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Shawnee Mission, Kansas, Forenede Stater, 66204
- Shawnee Mission Medical Center
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Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Forenede Stater, 67214
- Wesley Medical Center
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Forenede Stater, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Louisville Oncology at Norton Cancer Institute - Louisville
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Ochsner Health Center - Bluebonnet
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New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
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Maryland
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Bethesda, Maryland, Forenede Stater, 20814
- Suburban Hospital
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Elkton MD, Maryland, Forenede Stater, 21921
- Union Hospital Cancer Program at Union Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston University Cancer Research Center
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Plymouth, Massachusetts, Forenede Stater, 02360
- Jordan Hospital Club Cancer Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Forenede Stater, 49017
- Battle Creek Health System Cancer Care Center
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Bay City, Michigan, Forenede Stater, 48708
- Bay Regional Medical Center
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Big Rapids, Michigan, Forenede Stater, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Forenede Stater, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Forenede Stater, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Forenede Stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, Forenede Stater, 49201
- Foote Memorial Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, Forenede Stater, 48912-1811
- Sparrow Regional Cancer Center
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Lansing, Michigan, Forenede Stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Livonia, Michigan, Forenede Stater, 48154
- St. Mary Mercy Hospital
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Marquette, Michigan, Forenede Stater, 49855
- Upper Michigan Cancer Center at Marquette General Hospital
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Muskegon, Michigan, Forenede Stater, 49442
- Hackley Hospital
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Pontiac, Michigan, Forenede Stater, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Forenede Stater, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital - Royal Oak Campus
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Saginaw, Michigan, Forenede Stater, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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St. Joseph, Michigan, Forenede Stater, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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Warren, Michigan, Forenede Stater, 48093
- St. John Macomb Hospital
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Wyoming, Michigan, Forenede Stater, 49519
- Metro Health Hospital
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Duluth, Minnesota, Forenede Stater, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Forenede Stater, 55805
- Miller - Dwan Medical Center
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Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401
- Hattiesburg Clinic, PA at Forrest General
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Hattiesburg, Mississippi, Forenede Stater, 39402
- Hematology & Oncology Clinic
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Saint Francis Medical Center
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Cape Girardeau, Missouri, Forenede Stater, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Independence, Missouri, Forenede Stater, 64050
- Independence Regional Health Center
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Kansas City, Missouri, Forenede Stater, 64116
- North Kansas City Hospital
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Kansas City, Missouri, Forenede Stater, 64132
- Research Medical Center
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Kansas City, Missouri, Forenede Stater, 64108
- Truman Medical Center - Hospital Hill
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Kansas City, Missouri, Forenede Stater, 64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
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Kansas City, Missouri, Forenede Stater, 64114
- St. Joseph Medical Center
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Kansas City, Missouri, Forenede Stater, 64116
- Parvin Radiation Oncology
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Liberty, Missouri, Forenede Stater, 64068
- Liberty Hospital
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Saint Joseph, Missouri, Forenede Stater, 64506
- Heartland Regional Medical Center
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Saint Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Forenede Stater, 63109
- Midwest Hematology Oncology Group, Incorporated
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Saint Louis, Missouri, Forenede Stater, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Springfield, Missouri, Forenede Stater, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Forenede Stater, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Forenede Stater, 65807
- Hulston Cancer Center at Cox Medical Center South
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Forenede Stater, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Forenede Stater, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Forenede Stater, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Forenede Stater, 59107-7000
- Billings Clinic - Downtown
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Butte, Montana, Forenede Stater, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Forenede Stater, 59405
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Havre, Montana, Forenede Stater, 59501
- Northern Montana Hospital
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Forenede Stater, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Forenede Stater, 59801
- Community Medical Center
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Missoula, Montana, Forenede Stater, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Forenede Stater, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Forenede Stater, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Nevada Cancer Research Foundation
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New Jersey
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Voorhees, New Jersey, Forenede Stater, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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East Syracuse, New York, Forenede Stater, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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Ohio
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Bellefontaine, Ohio, Forenede Stater, 43311
- Mary Rutan Hospital
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Chillicothe, Ohio, Forenede Stater, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Forenede Stater, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Forenede Stater, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, Forenede Stater, 43215
- CCOP - Columbus
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Columbus, Ohio, Forenede Stater, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, Forenede Stater, 43228
- Doctors Hospital at Ohio Health
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Dayton, Ohio, Forenede Stater, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Delaware, Ohio, Forenede Stater, 43015
- Grady Memorial Hospital
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Lancaster, Ohio, Forenede Stater, 43130
- Fairfield Medical Center
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Marietta, Ohio, Forenede Stater, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Newark, Ohio, Forenede Stater, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Springfield, Ohio, Forenede Stater, 45505
- Community Hospital of Springfield and Clark County
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Springfield, Ohio, Forenede Stater, 45504
- Mercy Medical Center
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Westerville, Ohio, Forenede Stater, 43081
- Mount Carmel St. Ann's Cancer Center
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Zanesville, Ohio, Forenede Stater, 43701
- Genesis - Good Samaritan Hospital
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Bryn Mawr, Pennsylvania, Forenede Stater, 19010
- Bryn Mawr Hospital
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Paoli, Pennsylvania, Forenede Stater, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- UPMC Cancer Centers
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny Cancer Center at Allegheny General Hospital
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- CCOP - Main Line Health
-
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South Carolina
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Florence, South Carolina, Forenede Stater, 29501
- McLeod Regional Medical Center
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Texas
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Washington
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Forenede Stater, 98104
- Fred Hutchinson Cancer Research Center
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Wisconsin
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Eau Claire, Wisconsin, Forenede Stater, 54701
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
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Eau Claire, Wisconsin, Forenede Stater, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
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Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Forenede Stater, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Forenede Stater, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Marshfield, Wisconsin, Forenede Stater, 54449
- Saint Joseph's Hospital
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Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic - Marshfield Center
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Minocqua, Wisconsin, Forenede Stater, 54548
- Marshfield Clinic - Lakeland Center
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Rhinelander, Wisconsin, Forenede Stater, 54501
- Ministry Medical Group at Saint Mary's Hospital
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Rice Lake, Wisconsin, Forenede Stater, 54868
- Marshfield Clinic - Indianhead Center
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Stevens Point, Wisconsin, Forenede Stater, 54481
- Saint Michael's Hospital Cancer Center
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Wausau, Wisconsin, Forenede Stater, 54401
- Marshfield Clinic - Wausau Center
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Weston, Wisconsin, Forenede Stater, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Studiepopulationen, der skal interviewes, omfatter patienter, der blev behandlet for mindst 5 år siden for tyktarms- eller endetarmskræft i NSABP-forsøg R-02, R-03, C-05, C-06 eller C-07
Beskrivelse
SYGDOMS KARAKTERISTIKA:
- Forudgående diagnose af tyktarms- eller endetarmskræft
Mindst 5 år siden deltog i 1 af følgende kliniske forsøg:
- NSABP-R-02
- NSABP-R-03
- NSABP-C-05
- NSABP-C-06
- NSABP-C-07
PATIENT KARAKTERISTIKA:
- Kunne tale engelsk
FORUDSÆTNING SAMTYDLIG TERAPI:
- I henhold til deltagelseskrav i tidligere NSABP-behandlingsforsøg
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patienter behandlet i NSABP R-02, R-03, C-05, C-06 eller C-07
Studiepopulationen, der skal interviewes, omfatter patienter, der blev behandlet for mindst 5 år siden for tyktarms- eller endetarmskræft i NSABP-forsøg R-02, R-03, C-05, C-06 eller C-07
|
Telefoninterview for at vurdere generisk sundhedsstatus, livskvalitet, komorbiditet, indvirkning af kræft, brug af medicinske tjenester, sundhedsvurdering, smerter, træthed, dagligdags aktiviteter, demografi, funktionelt velvære (kun C-06) og neurotoksicitet (kun C-07)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Typer af patientrapporterede resultater
Tidsramme: Efter alle telefoninterviews er afsluttet
|
Undersøgelsesbatteri for livskvalitet, funktionelle resultater og kliniske symptomer fra patienter fra alle 5 spor
|
Efter alle telefoninterviews er afsluttet
|
|
I hvilken grad patientrapporterede resultater er påvirket af individuelle karakteristika, sundhedsadfærd og, når det er relevant, specifikke behandlinger, der blev modtaget
Tidsramme: Efter alle telefoninterviews er afsluttet
|
Langsigtede mentale og fysiske komponentskalaer, EORTC-CR 38, individuelle karakteristika og sundhedsadfærd, behandlingsoplysninger
|
Efter alle telefoninterviews er afsluttet
|
|
Sammenligning af patientrapporterede resultater før randomisering, 1 år efter afslutning af undersøgelsesbehandling og i langtidsopfølgning > 5 år efter diagnose hos patienter behandlet i NSABP C-06 eller NSABP C-07 forsøg
Tidsramme: Efter alle telefoninterviews er afsluttet
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Fire generiske subskalaer af FACT-C og kolorektal cancer subskalaen, total score for symptomer distress skala, SF-12 Vitality subscale og sundhedsvurderingsskala; NTX-R
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Efter alle telefoninterviews er afsluttet
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Norman Wolmark, MD, NSABP Foundation Inc
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kunitake H, Zheng P, Yothers G, et al.: Routine preventive care and cancer surveillance in long-term survivors (LTS) of colorectal cancer: results from NSABP Protocol LTS-01. [Abstract] J Clin Oncol 27 (Suppl 15): A-6500, 2009.
- Yothers G, Land SR, Ganz PA, et al.: Neurotoxicity (NT) in colon cancer (CC) survivors from NSABP Protocol C-07 comparing 5-FU + leucovorin (FULV) with the same regimen + oxaliplatin (FLOX): preliminary results from NSABP protocol LTS-01. [Abstract] J Clin Oncol 26 (Suppl 15): A-9575, 2008.
- Kunitake H, Zheng P, Yothers G, Land SR, Fehrenbacher L, Giguere JK, Wickerham DL, Ganz PA, Ko CY. Routine preventive care and cancer surveillance in long-term survivors of colorectal cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol LTS-01. J Clin Oncol. 2010 Dec 20;28(36):5274-9. doi: 10.1200/JCO.2010.30.1903. Epub 2010 Nov 15. Erratum In: J Clin Oncol. 2011 Feb 20;29(6):779. Wickerham, Lawrence [corrected to Wickerham, D Lawrence].
- Kunitake H, Russell MM, Zheng P, Yothers G, Land SR, Petersen L, Fehrenbacher L, Giguere JK, Wickerham DL, Ko CY, Ganz PA. Quality of life and symptoms in long-term survivors of colorectal cancer: results from NSABP protocol LTS-01. J Cancer Surviv. 2017 Feb;11(1):111-118. doi: 10.1007/s11764-016-0567-y. Epub 2016 Aug 25.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2006
Primær færdiggørelse (Faktiske)
1. februar 2009
Studieafslutning (Faktiske)
1. februar 2009
Datoer for studieregistrering
Først indsendt
11. december 2006
Først indsendt, der opfyldte QC-kriterier
11. december 2006
Først opslået (Skøn)
13. december 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. december 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. december 2010
Sidst verificeret
1. december 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NSABP LTS-01
- CDR0000494640 (Anden identifikator: NCI)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .