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

Sponsor
NSABP Foundation Inc (Other)
Overall Status
Completed
CT.gov ID
NCT00410579
Collaborator
National Cancer Institute (NCI) (NIH), University of California, Los Angeles (Other)
744
200
27
3.7
0.1

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
744 participants
Observational Model:
Cohort
Official Title:
Patient Reported Outcomes in Long Term Survivors With Colon and Rectal Cancer
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aurora Presbyterian Hospital Aurora Colorado United States 80012
2 Boulder Community Hospital Boulder Colorado United States 80301-9019
3 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
4 St. Anthony Central Hospital Denver Colorado United States 80204
5 Porter Adventist Hospital Denver Colorado United States 80210
6 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
7 St. Joseph Hospital Denver Colorado United States 80218
8 Rose Medical Center Denver Colorado United States 80220
9 CCOP - Colorado Cancer Research Program Denver Colorado United States 80224-2522
10 Swedish Medical Center Englewood Colorado United States 80110
11 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction Colorado United States 81502
12 North Colorado Medical Center Greeley Colorado United States 80631
13 Sky Ridge Medical Center Lone Tree Colorado United States 80124
14 Hope Cancer Care Center at Longmont United Hospital Longmont Colorado United States 80502
15 McKee Medical Center Loveland Colorado United States 80539
16 St. Mary - Corwin Regional Medical Center Pueblo Colorado United States 81004
17 North Suburban Medical Center Thornton Colorado United States 80229
18 Exempla Lutheran Medical Center Wheat Ridge Colorado United States 80033
19 Tunnell Cancer Center at Beebe Medical Center Lewes Delaware United States 19958
20 CCOP - Christiana Care Health Services Newark Delaware United States 19713
21 Piedmont Hospital Atlanta Georgia United States 30309
22 Northside Hospital Cancer Center Atlanta Georgia United States 30342-1611
23 Saint Joseph's Hospital of Atlanta Atlanta Georgia United States 30342-1701
24 CCOP - Atlanta Regional Atlanta Georgia United States 30342
25 WellStar Cobb Hospital Austell Georgia United States 30106
26 Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur Georgia United States 30033
27 Gwinnett Medical Center Lawrenceville Georgia United States 30045
28 Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta Georgia United States 30060
29 Southern Regional Medical Center Riverdale Georgia United States 30274-2600
30 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia United States 31403-3089
31 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
32 Saint Anthony's Hospital at Saint Anthony's Health Center Alton Illinois United States 62002
33 Rush-Copley Cancer Care Center Aurora Illinois United States 60504
34 Decatur Memorial Hospital Cancer Care Institute Decatur Illinois United States 62526
35 Evanston Northwestern Healthcare - Evanston Hospital Evanston Illinois United States 60201-1781
36 Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois United States 60435
37 Good Samaritan Regional Health Center Mt. Vernon Illinois United States 62864
38 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
39 CCOP - Carle Cancer Center Urbana Illinois United States 61801
40 Elkhart General Hospital Elkhart Indiana United States 46515
41 Howard Community Hospital Kokomo Indiana United States 46904
42 Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana United States 46350
43 Clarian Arnett Cancer Care Lafayette Indiana United States 47904
44 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
45 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
46 Memorial Hospital of South Bend South Bend Indiana United States 46601
47 Saint Joseph Regional Medical Center South Bend Indiana United States 46617
48 McFarland Clinic, PC Ames Iowa United States 50010
49 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
50 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
51 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
52 Cancer Center of Kansas, PA - Chanute Chanute Kansas United States 66720
53 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas United States 67801
54 Cancer Center of Kansas, PA - El Dorado El Dorado Kansas United States 67042
55 Cancer Center of Kansas-Independence Independence Kansas United States 67301
56 Cancer Center of Kansas, PA - Kingman Kingman Kansas United States 67068
57 Lawrence Memorial Hospital Lawrence Kansas United States 66044
58 Southwest Medical Center Liberal Kansas United States 67901
59 Cancer Center of Kansas, PA - Newton Newton Kansas United States 67114
60 Menorah Medical Center Overland Park Kansas United States 66209
61 Cancer Center of Kansas, PA - Parsons Parsons Kansas United States 67357
62 Cancer Center of Kansas, PA - Pratt Pratt Kansas United States 67124
63 Cancer Center of Kansas, PA - Salina Salina Kansas United States 67042
64 Shawnee Mission Medical Center Shawnee Mission Kansas United States 66204
65 Cancer Center of Kansas, PA - Wellington Wellington Kansas United States 67152
66 Associates in Womens Health, PA - North Review Wichita Kansas United States 67208
67 Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas United States 67208
68 Cancer Center of Kansas, PA - Wichita Wichita Kansas United States 67214
69 CCOP - Wichita Wichita Kansas United States 67214
70 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
71 Wesley Medical Center Wichita Kansas United States 67214
72 Cancer Center of Kansas, PA - Winfield Winfield Kansas United States 67156
73 Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky United States 40536-0093
74 Louisville Oncology at Norton Cancer Institute - Louisville Louisville Kentucky United States 40202
75 Ochsner Health Center - Bluebonnet Baton Rouge Louisiana United States 70809
76 CCOP - Ochsner New Orleans Louisiana United States 70121
77 Suburban Hospital Bethesda Maryland United States 20814
78 Union Hospital Cancer Program at Union Hospital Elkton MD Maryland United States 21921
79 Boston University Cancer Research Center Boston Massachusetts United States 02118
80 Jordan Hospital Club Cancer Center Plymouth Massachusetts United States 02360
81 Saint Joseph Mercy Cancer Center Ann Arbor Michigan United States 48106-0995
82 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
83 Battle Creek Health System Cancer Care Center Battle Creek Michigan United States 49017
84 Bay Regional Medical Center Bay City Michigan United States 48708
85 Mecosta County Medical Center Big Rapids Michigan United States 49307
86 Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan United States 48123-2500
87 Genesys Hurley Cancer Institute Flint Michigan United States 48503
88 Hurley Medical Center Flint Michigan United States 48503
89 Butterworth Hospital at Spectrum Health Grand Rapids Michigan United States 49503
90 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
91 Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan United States 49503
92 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
93 Foote Memorial Hospital Jackson Michigan United States 49201
94 Borgess Medical Center Kalamazoo Michigan United States 49001
95 West Michigan Cancer Center Kalamazoo Michigan United States 49007-3731
96 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
97 Breslin Cancer Center at Ingham Regional Medical Center Lansing Michigan United States 48910
98 Sparrow Regional Cancer Center Lansing Michigan United States 48912-1811
99 St. Mary Mercy Hospital Livonia Michigan United States 48154
100 Upper Michigan Cancer Center at Marquette General Hospital Marquette Michigan United States 49855
101 Hackley Hospital Muskegon Michigan United States 49442
102 St. Joseph Mercy Oakland Pontiac Michigan United States 48341-2985
103 Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan United States 48060
104 William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan United States 48073
105 Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan United States 48601
106 Lakeland Regional Cancer Care Center - St. Joseph St. Joseph Michigan United States 49085
107 Munson Medical Center Traverse City Michigan United States 49684
108 St. John Macomb Hospital Warren Michigan United States 48093
109 Metro Health Hospital Wyoming Michigan United States 49519
110 Duluth Clinic Cancer Center - Duluth Duluth Minnesota United States 55805-1983
111 CCOP - Duluth Duluth Minnesota United States 55805
112 Miller - Dwan Medical Center Duluth Minnesota United States 55805
113 Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota United States 55109
114 Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota United States 55125
115 Hattiesburg Clinic, PA at Forrest General Hattiesburg Mississippi United States 39401
116 Hematology & Oncology Clinic Hattiesburg Mississippi United States 39402
117 Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Cape Girardeau Missouri United States 63701
118 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
119 Independence Regional Health Center Independence Missouri United States 64050
120 Truman Medical Center - Hospital Hill Kansas City Missouri United States 64108
121 Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri United States 64111
122 St. Joseph Medical Center Kansas City Missouri United States 64114
123 North Kansas City Hospital Kansas City Missouri United States 64116
124 Parvin Radiation Oncology Kansas City Missouri United States 64116
125 CCOP - Kansas City Kansas City Missouri United States 64131
126 Research Medical Center Kansas City Missouri United States 64132
127 Liberty Hospital Liberty Missouri United States 64068
128 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
129 Midwest Hematology Oncology Group, Incorporated Saint Louis Missouri United States 63109
130 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
131 David C. Pratt Cancer Center at St. John's Mercy Saint Louis Missouri United States 63141
132 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65802
133 St. John's Regional Health Center Springfield Missouri United States 65804
134 Hulston Cancer Center at Cox Medical Center South Springfield Missouri United States 65807
135 CCOP - Montana Cancer Consortium Billings Montana United States 59101
136 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59101
137 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
138 St. Vincent Healthcare Cancer Care Services Billings Montana United States 59101
139 Billings Clinic - Downtown Billings Montana United States 59107-7000
140 St. James Healthcare Cancer Care Butte Montana United States 59701
141 Great Falls Clinic - Main Facility Great Falls Montana United States 59405
142 Great Falls Montana United States 59405
143 Northern Montana Hospital Havre Montana United States 59501
144 Glacier Oncology, PLLC Kalispell Montana United States 59901
145 Kalispell Medical Oncology at KRMC Kalispell Montana United States 59901
146 Kalispell Regional Medical Center Kalispell Montana United States 59901
147 Community Medical Center Missoula Montana United States 59801
148 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
149 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
150 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
151 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
152 CCOP - Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
153 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
154 CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York United States 13057
155 Mary Rutan Hospital Bellefontaine Ohio United States 43311
156 Adena Regional Medical Center Chillicothe Ohio United States 45601
157 Riverside Methodist Hospital Cancer Care Columbus Ohio United States 43214-3998
158 CCOP - Columbus Columbus Ohio United States 43215
159 Grant Medical Center Cancer Care Columbus Ohio United States 43215
160 Mount Carmel Health - West Hospital Columbus Ohio United States 43222
161 Doctors Hospital at Ohio Health Columbus Ohio United States 43228
162 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
163 Grady Memorial Hospital Delaware Ohio United States 43015
164 Fairfield Medical Center Lancaster Ohio United States 43130
165 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750
166 Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio United States 43055
167 Mercy Medical Center Springfield Ohio United States 45504
168 Community Hospital of Springfield and Clark County Springfield Ohio United States 45505
169 Mount Carmel St. Ann's Cancer Center Westerville Ohio United States 43081
170 Genesis - Good Samaritan Hospital Zanesville Ohio United States 43701
171 Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma United States 74136
172 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania United States 18105
173 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
174 Cancer Center of Paoli Memorial Hospital Paoli Pennsylvania United States 19301-1792
175 Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
176 UPMC Cancer Centers Pittsburgh Pennsylvania United States 15232
177 CCOP - Main Line Health Wynnewood Pennsylvania United States 19096
178 Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania United States 19096
179 McLeod Regional Medical Center Florence South Carolina United States 29501
180 Avera Cancer Institute Sioux Falls South Dakota United States 57105
181 Medical X-Ray Center, PC Sioux Falls South Dakota United States 57105
182 Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota United States 57117-5039
183 CCOP - Scott and White Hospital Temple Texas United States 76508
184 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
185 Fred Hutchinson Cancer Research Center Seattle Washington United States 98104
186 Center for Cancer Treatment & Prevention at Sacred Heart Hospital Eau Claire Wisconsin United States 54701
187 Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin United States 54701
188 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54301-3526
189 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
190 St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin United States 54303
191 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
192 Marshfield Clinic - Marshfield Center Marshfield Wisconsin United States 54449
193 Saint Joseph's Hospital Marshfield Wisconsin United States 54449
194 Marshfield Clinic - Lakeland Center Minocqua Wisconsin United States 54548
195 Ministry Medical Group at Saint Mary's Hospital Rhinelander Wisconsin United States 54501
196 Marshfield Clinic - Indianhead Center Rice Lake Wisconsin United States 54868
197 Saint Michael's Hospital Cancer Center Stevens Point Wisconsin United States 54481
198 Marshfield Clinic - Wausau Center Wausau Wisconsin United States 54401
199 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
200 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494

Sponsors and Collaborators

  • NSABP Foundation Inc
  • National Cancer Institute (NCI)
  • University of California, Los Angeles

Investigators

  • Study Chair: Norman Wolmark, MD, NSABP Foundation Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00410579
Other Study ID Numbers:
  • NSABP LTS-01
  • CDR0000494640
First Posted:
Dec 13, 2006
Last Update Posted:
Dec 17, 2010
Last Verified:
Dec 1, 2010

Study Results

No Results Posted as of Dec 17, 2010