Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers
- Conditions
- Colorectal CancerFatigueLong-term Effects Secondary to Cancer Therapy in AdultsPainPsychosocial Effects of Cancer and Its Treatment
- Interventions
- Other: Telephone interview
- Registration Number
- NCT00410579
- Lead Sponsor
- NSABP Foundation Inc
- 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.
- Detailed Description
OBJECTIVES:
* 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 demographics.
PROJECTED ACCRUAL: A total of 1,167 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 744
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients treated in NSABP R-02, R-03, C-05, C-06 or C-07 Telephone interview 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
- Primary Outcome Measures
Name Time Method 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 After all telephone interviews are completed 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
Types of patient-reported outcomes After all telephone interviews are completed Survey battery for quality of life, functional outcomes, and clinical symptoms from patients from all 5 trails
Degree to which patient-reported outcomes are impacted by individual characteristics, health behaviors, and when appropriate specific treatments that were received After all telephone interviews are completed Long Term Mental and Physical Component Scales, EORTC-CR 38, Individual Characteristics and Health Behaviors, treatment information
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (199)
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
CCOP - Main Line Health
🇺🇸Wynnewood, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Exempla Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Shawnee Mission Medical Center
🇺🇸Shawnee Mission, Kansas, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton MD, Maryland, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Bay Regional Medical Center
🇺🇸Bay City, Michigan, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Jordan Hospital Club Cancer Center
🇺🇸Plymouth, Massachusetts, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸St. Joseph, Michigan, United States
Saint Joseph's Hospital
🇺🇸Marshfield, Wisconsin, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Hattiesburg Clinic, PA at Forrest General
🇺🇸Hattiesburg, Mississippi, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Ochsner Health Center - Bluebonnet
🇺🇸Baton Rouge, Louisiana, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
🇺🇸Eau Claire, Wisconsin, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Upper Michigan Cancer Center at Marquette General Hospital
🇺🇸Marquette, Michigan, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Saint Michael's Hospital Cancer Center
🇺🇸Stevens Point, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
🇺🇸Eau Claire, Wisconsin, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
McLeod Regional Medical Center
🇺🇸Florence, South Carolina, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Marshfield Clinic - Lakeland Center
🇺🇸Minocqua, Wisconsin, United States
Marshfield Clinic - Wausau Center
🇺🇸Wausau, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
🇺🇸Wisconsin Rapids, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
🇺🇸Rhinelander, Wisconsin, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Marshfield Clinic - Indianhead Center
🇺🇸Rice Lake, Wisconsin, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
WellStar Cobb Hospital
🇺🇸Austell, Georgia, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
North Suburban Medical Center
🇺🇸Thornton, Colorado, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Cape Girardeau, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
St. Mary - Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
McKee Medical Center
🇺🇸Loveland, Colorado, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Northside Hospital Cancer Center
🇺🇸Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Southern Regional Medical Center
🇺🇸Riverdale, Georgia, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Evanston Northwestern Healthcare - Evanston Hospital
🇺🇸Evanston, Illinois, United States
Good Samaritan Regional Health Center
🇺🇸Mt. Vernon, Illinois, United States
Clarian Arnett Cancer Care
🇺🇸Lafayette, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
Independence Regional Health Center
🇺🇸Independence, Missouri, United States
Midwest Hematology Oncology Group, Incorporated
🇺🇸Saint Louis, Missouri, United States
Hematology & Oncology Clinic
🇺🇸Hattiesburg, Mississippi, United States
Liberty Hospital
🇺🇸Liberty, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Parvin Radiation Oncology
🇺🇸Kansas City, Missouri, United States
St. Joseph Medical Center
🇺🇸Kansas City, Missouri, United States
North Kansas City Hospital
🇺🇸Kansas City, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
Louisville Oncology at Norton Cancer Institute - Louisville
🇺🇸Louisville, Kentucky, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Truman Medical Center - Hospital Hill
🇺🇸Kansas City, Missouri, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States