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Patient Reported Outcomes in Long Term Survivors With Colon and Rectal Cancer

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Colorectal Cancer, Fatigue, Long-term Effects Secondary to Cancer Therapy in Adults, Pain, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

Patient Reported Outcomes in Long Term Survivors With Colon and Rectal Cancer


- Characterize 3 separate types of patient-reported outcomes (quality of life [e.g.,
generic and disease-specific], functional outcomes [e.g., bowel and sexual function and
activities of daily living], and clinical symptoms [e.g., pain, fatigue]) in long-term
(5+ years) survivors of colon and rectal cancers in a large national sample recruited
from five National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment trials.

- Explore the degree to which patient-reported outcomes are impacted by individual
characteristics (e.g., specific predisposing factors, enabling resources, and need), by
health behaviors (e.g., use of services for cancer-related and non-cancer-related
issues), and, when appropriate, by the specific treatments that were received.

- Examine patient-reported outcomes prior to randomization and treatment, 1 year after
treatment, and in long-term follow up > 5 years after diagnosis in patients with colon
cancer treated with adjuvant chemotherapy on protocols NSABP C-06 or NSABP C-07.

OUTLINE: This is a cohort, single-group, multicenter study.

Patients complete a one-time, computer-assisted telephone interview assessing their overall
quality of life (QOL), disease-specific QOL, function and symptoms (including pain and
fatigue), use of healthcare services, prevalence and severity of comorbidity, and

PROJECTED ACCRUAL: A total of 1,167 patients will be accrued for this study.

Inclusion Criteria


- Prior diagnosis of colon or rectal cancer

- At least 5 years since participated in 1 of the following clinical trials:

- NSABP-R-02

- NSABP-R-03

- NSABP-C-05

- NSABP-C-06

- NSABP-C-07


- Able to speak English


- As per participation requirements of previous NSABP treatment trials

Type of Study:


Study Design:

Observational Model: Cohort

Outcome Measure:

Types of patient-reported outcomes

Outcome Description:

Survey battery for quality of life, functional outcomes, and clinical symptoms from patients from all 5 trails

Outcome Time Frame:

After all telephone interviews are completed

Safety Issue:


Principal Investigator

Norman Wolmark, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Surgical Adjuvant Breast and Bowel Project (NSABP)


United States: Federal Government

Study ID:




Start Date:

November 2006

Completion Date:

February 2009

Related Keywords:

  • Colorectal Cancer
  • Fatigue
  • Long-term Effects Secondary to Cancer Therapy in Adults
  • Pain
  • Psychosocial Effects of Cancer and Its Treatment
  • pain
  • fatigue
  • long-term effects secondary to cancer therapy in adults
  • psychosocial effects of cancer and its treatment
  • stage II rectal cancer
  • stage III rectal cancer
  • stage II colon cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Fatigue



Suburban Hospital Bethesda, Maryland  20814
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
CCOP - Colorado Cancer Research Program Denver, Colorado  80224-2522
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
St. Mary - Corwin Regional Medical Center Pueblo, Colorado  81004
North Suburban Medical Center Thornton, Colorado  80229
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Evanston Northwestern Healthcare - Evanston Hospital Evanston, Illinois  60201-1781
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Marshfield Clinic - Indianhead Center Rice Lake, Wisconsin  54868
CCOP - Ochsner New Orleans, Louisiana  70121
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
CCOP - Grand Rapids Grand Rapids, Michigan  49503
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Wesley Medical Center Wichita, Kansas  67214
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Southwest Medical Center Liberal, Kansas  67901
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Hackley Hospital Muskegon, Michigan  49443
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Munson Medical Center Traverse City, Michigan  49684
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
UPMC Cancer Centers Pittsburgh, Pennsylvania  15232
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Bay Regional Medical Center Bay City, Michigan  48708
Mecosta County Medical Center Big Rapids, Michigan  49307
Upper Michigan Cancer Center at Marquette General Hospital Marquette, Michigan  49855
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Mercy Medical Center Springfield, Ohio  45504
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
St. Anthony Central Hospital Denver, Colorado  80204-1335
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Allegheny Cancer Center at Allegheny General Hospital Pittsburgh, Pennsylvania  15212
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Menorah Medical Center Overland Park, Kansas  66209
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Ochsner Health Center - Bluebonnet Baton Rouge, Louisiana  70809
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
St. Joseph Medical Center Kansas City, Missouri  64114
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Billings Clinic - Downtown Billings, Montana  59107-7000
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Center for Cancer Treatment & Prevention at Sacred Heart Hospital Eau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Saint Joseph's Hospital Marshfield, Wisconsin  54449
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Saint Michael's Hospital Cancer Center Stevens Point, Wisconsin  54481
Marshfield Clinic - Wausau Center Wausau, Wisconsin  54401
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Jordan Hospital Club Cancer Center Plymouth, Massachusetts  02360
McLeod Regional Medical Center Florence, South Carolina  29501
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Louisville Oncology at Norton Cancer Institute - Louisville Louisville, Kentucky  40202
Boston University Cancer Research Center Boston, Massachusetts  02118
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Independence Regional Health Center Independence, Missouri  64050
Parvin Radiation Oncology Kansas City, Missouri  64116
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Hattiesburg Clinic, PA at Forrest General Hattiesburg, Mississippi  39401
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
Hematology & Oncology Clinic Hattiesburg, Mississippi  39402
Clarian Arnett Cancer Care Lafayette, Indiana  47904