Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers

December 15, 2010 updated by: NSABP Foundation Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: Telephone interview

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.

Study Type

Observational

Enrollment (Actual)

744

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Colorado
  - Aurora, Colorado, United States, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, United States, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, United States, 80218
    - St. Joseph Hospital
  - Denver, Colorado, United States, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Grand Junction, Colorado, United States, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80502
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Pueblo, Colorado, United States, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Tunnell Cancer Center at Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - CCOP - Christiana Care Health Services
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, United States, 30342-1611
    - Northside Hospital Cancer Center
  - Atlanta, Georgia, United States, 30342-1701
    - Saint Joseph's Hospital of Atlanta
  - Atlanta, Georgia, United States, 30342
    - CCOP - Atlanta Regional
  - Austell, Georgia, United States, 30106
    - WellStar Cobb Hospital
  - Decatur, Georgia, United States, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Lawrenceville, Georgia, United States, 30045
    - Gwinnett Medical Center
  - Marietta, Georgia, United States, 30060
    - Kennestone Cancer Center at Wellstar Kennestone Hospital
  - Riverdale, Georgia, United States, 30274-2600
    - Southern Regional Medical Center
  - Savannah, Georgia, United States, 31403-3089
    - Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Cancer Research Center of Hawaii
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Cancer Care Center
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Evanston, Illinois, United States, 60201-1781
    - Evanston Northwestern Healthcare - Evanston Hospital
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Mt. Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Lafayette, Indiana, United States, 47904
    - Clarian Arnett Cancer Care
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, United States, 46617
    - Saint Joseph Regional Medical Center
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - Southwest Medical Center
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - Salina
  - Shawnee Mission, Kansas, United States, 66204
    - Shawnee Mission Medical Center
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67214
    - Wesley Medical Center
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Kentucky
  - Lexington, Kentucky, United States, 40536-0093
    - Lucille P. Markey Cancer Center at University of Kentucky
  - Louisville, Kentucky, United States, 40202
    - Louisville Oncology at Norton Cancer Institute - Louisville
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center - Bluebonnet
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
- Maryland
  - Bethesda, Maryland, United States, 20814
    - Suburban Hospital
  - Elkton MD, Maryland, United States, 21921
    - Union Hospital Cancer Program at Union Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston University Cancer Research Center
  - Plymouth, Massachusetts, United States, 02360
    - Jordan Hospital Club Cancer Center
- Michigan
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, United States, 49017
    - Battle Creek Health System Cancer Care Center
  - Bay City, Michigan, United States, 48708
    - Bay Regional Medical Center
  - Big Rapids, Michigan, United States, 49307
    - Mecosta County Medical Center
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, United States, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Lansing, Michigan, United States, 48910
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Marquette, Michigan, United States, 49855
    - Upper Michigan Cancer Center at Marquette General Hospital
  - Muskegon, Michigan, United States, 49442
    - Hackley Hospital
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - St. Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, United States, 55805
    - Miller - Dwan Medical Center
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Mississippi
  - Hattiesburg, Mississippi, United States, 39401
    - Hattiesburg Clinic, PA at Forrest General
  - Hattiesburg, Mississippi, United States, 39402
    - Hematology & Oncology Clinic
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63701
    - Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  - Independence, Missouri, United States, 64050
    - Independence Regional Health Center
  - Kansas City, Missouri, United States, 64131
    - CCOP - Kansas City
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Center - Hospital Hill
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute at Saint Luke's Hospital
  - Kansas City, Missouri, United States, 64114
    - St. Joseph Medical Center
  - Kansas City, Missouri, United States, 64116
    - Parvin Radiation Oncology
  - Liberty, Missouri, United States, 64068
    - Liberty Hospital
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, United States, 63109
    - Midwest Hematology Oncology Group, Incorporated
  - Saint Louis, Missouri, United States, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Butte, Montana, United States, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, United States, 59405
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, United States, 59801
    - Community Medical Center
  - Missoula, Montana, United States, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Jersey
  - Voorhees, New Jersey, United States, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
- New York
  - East Syracuse, New York, United States, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
- Ohio
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, United States, 45504
    - Mercy Medical Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Paoli, Pennsylvania, United States, 19301-1792
    - Cancer Center of Paoli Memorial Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - UPMC Cancer Centers
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny Cancer Center at Allegheny General Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Cancer Center at Lankenau Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - Main Line Health
- South Carolina
  - Florence, South Carolina, United States, 29501
    - McLeod Regional Medical Center
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, United States, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Texas
  - Temple, Texas, United States, 76508
    - CCOP - Scott and White Hospital
- Washington
  - Seattle, Washington, United States, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, United States, 98104
    - Fred Hutchinson Cancer Research Center
- Wisconsin
  - Eau Claire, Wisconsin, United States, 54701
    - Center for Cancer Treatment & Prevention at Sacred Heart Hospital
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Marshfield, Wisconsin, United States, 54449
    - Saint Joseph's Hospital
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic - Marshfield Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic - Lakeland Center
  - Rhinelander, Wisconsin, United States, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic - Indianhead Center
  - Stevens Point, Wisconsin, United States, 54481
    - Saint Michael's Hospital Cancer Center
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic - Wausau Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Able to speak English

PRIOR CONCURRENT THERAPY:

As per participation requirements of previous NSABP treatment trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Telephone interview 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types of patient-reported outcomes Time Frame: After all telephone interviews are completed	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 Time Frame: After all telephone interviews are completed	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 Time Frame: 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	After all telephone interviews are completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NSABP Foundation Inc

Collaborators

National Cancer Institute (NCI)

University of California, Los Angeles

Investigators

Study Chair: Norman Wolmark, MD, NSABP Foundation Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 11, 2006

First Submitted That Met QC Criteria

December 11, 2006

First Posted (Estimate)

December 13, 2006

Study Record Updates

Last Update Posted (Estimate)

December 17, 2010

Last Update Submitted That Met QC Criteria

December 15, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NSABP LTS-01
CDR0000494640 (Other Identifier: NCI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Centre Hospitalier Universitaire de Saint Etienne

Not yet recruiting

Three-month Follow-up Analysis of Social Recommendations Issued by the Mobile Geriatric Team (UMG-CHUSE)

Geriatric | Care Coordination | Readmission, Hospital

France
Centre Hospitalier le Mans

Unknown

Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

Osteoporosis | Osteoporotic Fractures

France
Hillel Yaffe Medical Center

Unknown

The Long-term Neurodevelopmental Outcome After Intraventricular Hemorrhage (IVH)-Grades I-II in Preterm Infants at Ages 1-7 Years

Premature Infants

Israel
Papworth Hospital NHS Foundation Trust

Unknown

Prospective Identification of High-risk Coronary Plaques Through Non-invasive Imaging

Coronary Plaques
Assistance Publique - Hôpitaux de Paris

Recruiting

What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child? (MICE)

Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child

France
University Hospital, Bordeaux

Active, not recruiting

Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients (PAPASéPA)

Stroke | Stroke Sequelae

France
Fundación Pública Andaluza para la Investigación...

Unknown

Cognitive Outcomes During COVID-19 confiNemeNt in Elderly and Their Caregivers Using Technologies for DEMentia (CONNECTDEM)

Dementia | Mild Cognitive Impairment

Spain
University Hospital, Angers

Completed

ACTRAMAT-D: Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation (ACTRAMAT-D)

Pregnancy Loss

France

Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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