NCT00692211

Brief Summary

We will evaluate if we can increase colorectal cancer screening rates by directly sending screening tests to patients rather than waiting for them to come to clinic visits. We are also evaluating a new test--fecal immunochemical tests--which does not require patients to make dietary or medication changes. We will see if patients are more likely to complete these tests than the standard fecal occult blood tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

August 26, 2014

Completed
Last Updated

May 13, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

June 3, 2008

Results QC Date

August 11, 2014

Last Update Submit

April 28, 2015

Conditions

Keywords

screening

Outcome Measures

Primary Outcomes (1)

  • Colorectal Cancer Screening

    Completing fecal blood test within 90 days of enrolling

    3 months

Study Arms (2)

Arm 1: Fecal Immunochemical Tests

EXPERIMENTAL

Mailed fecal immunochemical tests

Other: Mailed fecal immunochemical tests

Arm 2: Fecal Occult Blood Tests

EXPERIMENTAL

Mailed fecal occult blood tests

Other: Mailed fecal occult blood tests

Interventions

Stool blood test

Arm 2: Fecal Occult Blood Tests

Stool blood test

Arm 1: Fecal Immunochemical Tests

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for stool-based colorectal cancer screening, followed in primary care clinic

You may not qualify if:

  • Need for surveillance or screening colonoscopy
  • limited life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

Location

Related Publications (2)

  • Hoffman RM, Steel SR, Yee EF, Massie L, Schrader RM, Moffett ML, Murata GH. A system-based intervention to improve colorectal cancer screening uptake. Am J Manag Care. 2011 Jan;17(1):49-55.

  • Hoffman RM, Steel S, Yee EF, Massie L, Schrader RM, Murata GH. Colorectal cancer screening adherence is higher with fecal immunochemical tests than guaiac-based fecal occult blood tests: a randomized, controlled trial. Prev Med. 2010 May-Jun;50(5-6):297-9. doi: 10.1016/j.ypmed.2010.03.010. Epub 2010 Mar 20.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Richard Hoffman, MD
Organization
New Mexico VA Health Care System

Study Officials

  • Richard M Hoffman, MD

    New Mexico VA Health Care System, Albuquerque, NM

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 6, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 13, 2015

Results First Posted

August 26, 2014

Record last verified: 2015-04

Locations