Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers
Patient Reported Outcomes in Long Term Survivors With Colon and Rectal Cancer
2 other identifiers
observational
744
1 country
200
Brief Summary
RATIONALE: Learning about quality of life, symptoms, and health behaviors in colorectal cancer survivors may help to determine the long-term effects of colon and rectal cancer treatments and may help to improve the quality of life for future cancer survivors. PURPOSE: This clinical trial is looking at patient-reported outcomes in long-term survivors of colon and rectal cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2006
Typical duration for all trials
200 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 11, 2006
CompletedFirst Posted
Study publicly available on registry
December 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedDecember 17, 2010
December 1, 2010
2.3 years
December 11, 2006
December 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Types of patient-reported outcomes
Survey battery for quality of life, functional outcomes, and clinical symptoms from patients from all 5 trails
After all telephone interviews are completed
Degree to which patient-reported outcomes are impacted by individual characteristics, health behaviors, and when appropriate specific treatments that were received
Long Term Mental and Physical Component Scales, EORTC-CR 38, Individual Characteristics and Health Behaviors, treatment information
After all telephone interviews are completed
Comparison of patient-reported outcomes prior to randomization, 1 year after completion of study treatment, and in long-term follow up > 5 years after diagnosis in patients treated in NSABP C-06 or NSABP C-07 trials
Four generic subscales of FACT-C and the colorectal cancer subscale, total score of symptoms distress scale, SF-12 Vitality subscale and health rating scale; NTX-R
After all telephone interviews are completed
Study Arms (1)
Patients treated in NSABP R-02, R-03, C-05, C-06 or C-07
Study population to be interviewed comprises patients who were treated at least 5 years ago for colon or rectal cancer in NSABP trials R-02, R-03, C-05, C-06 or C-07
Interventions
Telephone interview to assess generic health status, quality of life, comorbidity, impact of cancer, use of medical services, health rating, pain, fatigue, activities of daily living, demographics, functional well-being(C-06 only), and neurotoxicity (C-07 only)
Eligibility Criteria
Study population to be interviewed comprises patients who were treated at least 5 years ago for colon or rectal cancer in NSABP trials R-02, R-03, C-05, C-06 or C-07
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- NSABP Foundation Inclead
- National Cancer Institute (NCI)collaborator
- University of California, Los Angelescollaborator
Study Sites (200)
Aurora Presbyterian Hospital
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301-9019, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
St. Anthony Central Hospital
Denver, Colorado, 80204, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
St. Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80224-2522, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80502, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Northside Hospital Cancer Center
Atlanta, Georgia, 30342-1611, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342-1701, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342, United States
WellStar Cobb Hospital
Austell, Georgia, 30106, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, 30033, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274-2600, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403-3089, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, 62002, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60504, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526, United States
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, 60201-1781, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, 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
Clarian Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67042, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, 40536-0093, United States
Louisville Oncology at Norton Cancer Institute - Louisville
Louisville, Kentucky, 40202, United States
Ochsner Health Center - Bluebonnet
Baton Rouge, Louisiana, 70809, United States
CCOP - Ochsner
New Orleans, Louisiana, 70121, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, 21921, United States
Boston University Cancer Research Center
Boston, Massachusetts, 02118, United States
Jordan Hospital Club Cancer Center
Plymouth, Massachusetts, 02360, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017, United States
Bay Regional Medical Center
Bay City, Michigan, 48708, United States
Mecosta County Medical Center
Big Rapids, Michigan, 49307, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, 48910, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, 49855, United States
Hackley Hospital
Muskegon, Michigan, 49442, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota, 55805, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
Hattiesburg Clinic, PA at Forrest General
Hattiesburg, Mississippi, 39401, United States
Hematology & Oncology Clinic
Hattiesburg, Mississippi, 39402, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Independence Regional Health Center
Independence, Missouri, 64050, 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
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Liberty Hospital
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
Midwest Hematology Oncology Group, Incorporated
St Louis, Missouri, 63109, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Unknown Facility
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, 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
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
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus, Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055, United States
Mercy Medical Center
Springfield, Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, 43081, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18105, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
McLeod Regional Medical Center
Florence, South Carolina, 29501, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98104, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, 54548, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, 54868, United States
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin, 54481, United States
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Related Publications (3)
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.
PMID: 21079140RESULTYothers 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.
RESULTKunitake 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.
PMID: 27562475DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Norman Wolmark, MD
NSABP Foundation Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
December 11, 2006
First Posted
December 13, 2006
Study Start
November 1, 2006
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
December 17, 2010
Record last verified: 2010-12