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AzTrials

Colorectal CancerNCT00410579

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

An observational study of Colorectal Cancer and Fatigue, run by NSABP Foundation Inc at 200 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Telephone interview
How many people
744 participants
Where
200 sitesUnited States
Study dates
Nov 2006to Feb 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

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

Trial locations and contacts

200 sites in 1 country.

200 sites in 1 country

United States200 sites

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Ochsner Health Center - Bluebonnet

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • 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

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224-2522

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • 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

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • 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

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Hattiesburg Clinic, PA at Forrest General

    Hattiesburg, Mississippi, 39401

  • Hematology & Oncology Clinic

    Hattiesburg, Mississippi, 39402

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Independence Regional Health Center

    Independence, Missouri, 64050

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Clarian Arnett Cancer Care

    Lafayette, Indiana, 47904

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Liberty Hospital

    Liberty, Missouri, 64068

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80502

  • Louisville Oncology at Norton Cancer Institute - Louisville

    Louisville, Kentucky, 40202

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Upper Michigan Cancer Center at Marquette General Hospital

    Marquette, Michigan, 49855

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Jordan Hospital Club Cancer Center

    Plymouth, Massachusetts, 02360

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • St. Mary - Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274-2600

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Midwest Hematology Oncology Group, Incorporated

    St Louis, Missouri, 63109

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Saint Michael's Hospital Cancer Center

    Stevens Point, Wisconsin, 54481

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Marshfield Clinic - Wausau Center

    Wausau, Wisconsin, 54401

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • 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 - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

  • CCOP - Main Line Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Telephone interview
Keywords
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
Medical subject headings
Colorectal Neoplasms, Fatigue, Pain, Rectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telephone interviewOther

    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)

Study groups in NCT00410579
Study groupRoleWhat they receive
Patients treated in NSABP R-02, R-03, C-05, C-06 or C-07Study 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
Receives: Other: Telephone interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Types of patient-reported outcomes

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

    Measured: After all telephone interviews are completed

  2. 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

    Measured: After all telephone interviews are completed

  3. 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

    Measured: After all telephone interviews are completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
744 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410579
Sponsor's protocol ID
NSABP LTS-01
Other IDs
CDR0000494640
Status last verified
Dec 2010
First submitted
11 Dec 2006
Last updated
17 Dec 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21079140

  • 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, 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.

    PubMed 27562475

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer and Fatigue, run by NSABP Foundation Inc at 200 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 200 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Types of patient-reported outcomes (time frame: After all telephone interviews are completed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00410579, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2010.

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