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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410579
• Other study ID #: NSABP LTS-01
• Secondary ID: CDR0000494640
• Status: Completed
• Phase: N/A
• First received: December 11, 2006
• Last updated: December 15, 2010
• Start date: November 2006
• Est. completion date: February 2009

Study information

• Verified date: December 2010
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Instutional Review Board
• Study type: Observational

Clinical 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.

PURPOSE: This clinical trial is looking at patient-reported outcomes in long-term survivors of colon and rectal cancers.

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 information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois
United States	McFarland Clinic, PC	Ames	Iowa
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Northside Hospital Cancer Center	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Aurora Presbyterian Hospital	Aurora	Colorado
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	WellStar Cobb Hospital	Austell	Georgia
United States	Ochsner Health Center - Bluebonnet	Baton Rouge	Louisiana
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	Bay Regional Medical Center	Bay City	Michigan
United States	Mary Rutan Hospital	Bellefontaine	Ohio
United States	Suburban Hospital	Bethesda	Maryland
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Boulder Community Hospital	Boulder	Colorado
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	St. James Healthcare Cancer Care	Butte	Montana
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Cape Girardeau	Missouri
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Grady Memorial Hospital	Delaware	Ohio
United States	CCOP - Colorado Cancer Research Program	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian - St. Luke's Medical Center	Denver	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	St. Anthony Central Hospital	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	CCOP - Duluth	Duluth	Minnesota
United States	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota
United States	Miller - Dwan Medical Center	Duluth	Minnesota
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Center for Cancer Treatment & Prevention at Sacred Heart Hospital	Eau Claire	Wisconsin
United States	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Union Hospital Cancer Program at Union Hospital	Elkton MD	Maryland
United States	Swedish Medical Center	Englewood	Colorado
United States	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	McLeod Regional Medical Center	Florence	South Carolina
United States	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Hattiesburg Clinic, PA at Forrest General	Hattiesburg	Mississippi
United States	Hematology & Oncology Clinic	Hattiesburg	Mississippi
United States	Northern Montana Hospital	Havre	Montana
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	Independence Regional Health Center	Independence	Missouri
United States	Foote Memorial Hospital	Jackson	Michigan
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology at KRMC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	CCOP - Kansas City	Kansas City	Missouri
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Parvin Radiation Oncology	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri
United States	St. Joseph Medical Center	Kansas City	Missouri
United States	Truman Medical Center - Hospital Hill	Kansas City	Missouri
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Howard Community Hospital	Kokomo	Indiana
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Clarian Arnett Cancer Care	Lafayette	Indiana
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Breslin Cancer Center at Ingham Regional Medical Center	Lansing	Michigan
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware
United States	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky
United States	Southwest Medical Center	Liberal	Kansas
United States	Liberty Hospital	Liberty	Missouri
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado
United States	Louisville Oncology at Norton Cancer Institute - Louisville	Louisville	Kentucky
United States	McKee Medical Center	Loveland	Colorado
United States	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota
United States	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Upper Michigan Cancer Center at Marquette General Hospital	Marquette	Michigan
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Saint Joseph's Hospital	Marshfield	Wisconsin
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin
United States	Community Medical Center	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Good Samaritan Regional Health Center	Mt. Vernon	Illinois
United States	Hackley Hospital	Muskegon	Michigan
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Menorah Medical Center	Overland Park	Kansas
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania
United States	Jordan Hospital Club Cancer Center	Plymouth	Massachusetts
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado
United States	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin
United States	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin
United States	Southern Regional Medical Center	Riverdale	Georgia
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Heartland Regional Medical Center	Saint Joseph	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	Midwest Hematology Oncology Group, Incorporated	Saint Louis	Missouri
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Shawnee Mission Medical Center	Shawnee Mission	Kansas
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Medical X-Ray Center, PC	Sioux Falls	South Dakota
United States	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Mercy Medical Center	Springfield	Ohio
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Lakeland Regional Cancer Care Center - St. Joseph	St. Joseph	Michigan
United States	Saint Michael's Hospital Cancer Center	Stevens Point	Wisconsin
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	North Suburban Medical Center	Thornton	Colorado
United States	Munson Medical Center	Traverse City	Michigan
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	St. John Macomb Hospital	Warren	Michigan
United States	Marshfield Clinic - Wausau Center	Wausau	Wisconsin
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio
United States	Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
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	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin
United States	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota
United States	CCOP - Main Line Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	Metro Health Hospital	Wyoming	Michigan
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
NSABP Foundation Inc	National Cancer Institute (NCI), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

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 Projec — View Citation

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 Cli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No