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The Identification of Prognostic Factors of Late Stage Disease, Particularly Those That Are Modifiable, That Might Explain the Worsened Prognosis With Colorectal Cancer Among Veterans.

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Colorectal Cancer focused on measuring colorectal cancer

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Colorectal cancer patients at the 14 participating sites Exclusion Criteria:

Sites / Locations

  • Durham VA Medical Center HSR&D COE

Arms of the Study

Arm 1

Arm Type

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 29, 2000
Last Updated
February 2, 2011
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00007618
Brief Title
The Identification of Prognostic Factors of Late Stage Disease, Particularly Those That Are Modifiable, That Might Explain the Worsened Prognosis With Colorectal Cancer Among Veterans.
Official Title
CSP #707D - Colorectal Cancer-Risk Factors for Advanced Disease
Study Type
Observational

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Colorectal cancer is the second leading cause of cancer death in the United States each year. Approximately one million veterans aged 50 and older will develop colorectal cancer over the remainder of their lives and nearly 433,000 will die from it. Because most cancers are diagnosed after local or regional spread, nearly half of all patients diagnosed with colorectal cancer will die. On a national basis, the relative five year survival with colorectal cancer was estimated at approximately 40% among veterans, substantially lower than SEER estimates in the general population of 61.7% (colon) and 59.3% (rectum). Colorectal cancer is preventable through screening, however and, if diagnosed in an early stage (Dukes' A and B), is curable. This is the first study to examine factors that might explain the worsened prognosis for veterans with colorectal cancer. If modifiable factors such as physician and patient delay in diagnosis, or poverty, explain the increased mortality among veterans, educational programs and interventions that improve the process of care associated with screening and diagnosis can be instituted.
Detailed Description
Primary Objectives: To identify prognostic factors of late stage disease, particularly those that are modifiable, that might explain the worsened prognosis with colorectal cancer among veterans and that also might be responsive to intervention. Interventions directed at these factors could lead to a decreased mortality among veterans. Secondary Objectives: To compare outcomes among veterans with similar non-veterans who are participating in the NCI-funded study: "Population Study of Colon Cancer in Blacks and Whites" that is in-progress at the University of North Carolina at Chapel Hill. Primary Outcomes: The primary outcomes are stage of disease and delay of diagnosis. Delay of diagnosis is determined by length of time between symptom onset and medical consultation (patient delay) and length of time between first seeking medical consultation and diagnosis (physician or system delay). Stage of disease will be used as a proxy for survival. Intervention: N/A Study Abstract: Colorectal cancer is the second leading cause of cancer death in the United States each year. Approximately one million veterans aged 50 and older will develop colorectal cancer over the remainder of their lives and nearly 433,000 will die from it. Because most cancers are diagnosed after local or regional spread, nearly half of all patients diagnosed with colorectal cancer will die. On a national basis, the relative five year survival with colorectal cancer was estimated at approximately 40% among veterans, substantially lower than SEER estimates in the general population of 61.7% (colon) and 59.3% (rectum). Colorectal cancer is preventable through screening, however and, if diagnosed in an early stage (Dukes' A and B), is curable. This is the first study to examine factors that might explain the worsened prognosis for veterans with colorectal cancer. If modifiable factors such as physician and patient delay in diagnosis, or poverty, explain the increased mortality among veterans, educational programs and interventions that improve the process of care associated with screening and diagnosis can be instituted. To-date, 659 subjects have been enrolled. Study participation involves obtaining demographic, pathology and patient contact data on all colorectal cancer patients at the 14 participating sites and conducting a one-time telephone interview. Preliminary study data suggests that most veterans with colorectal cancer present with evidence of regional or distant spread of their colorectal cancer. No significant difference in stage at presentation among veterans versus the population-based SEER patients is evident. Fewer veterans present with localized disease (33% versus 40%) and, although not statistically significant, could suggest a trend toward presentation at a more advanced stage. Results of this study will provide a profile of patients at high-risk of presenting with advanced colorectal cancer. This profile may be useful in designing patient and health care system focused interventions to improve stage at diagnosis. Final Results: Analyses are underway. A Final Report will be submitted to Durham ERIC within 90 days of study end date (03/31/02).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer

7. Study Design

8. Arms, Groups, and Interventions

Arm Title
1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Colorectal cancer patients at the 14 participating sites Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Provenzale, MD MS
Organizational Affiliation
Durham VA Medical Center HSR&D COE
Official's Role
Study Chair
Facility Information:
Facility Name
Durham VA Medical Center HSR&D COE
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Identification of Prognostic Factors of Late Stage Disease, Particularly Those That Are Modifiable, That Might Explain the Worsened Prognosis With Colorectal Cancer Among Veterans.

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