NCT00534053

Brief Summary

The purpose of our randomized controlled trial is to determine whether mailed educational reminders would increase fecal occult blood test (FOBT) card return rates and, therefore, improve patient compliance with colonrectal cancer (CRC) screening. We will conduct a randomized, controlled trial to evaluate the hypothesis that compliance to FOBT referrals is at least 10% greater among patients who receive mailed educational reminders on the importance of CRC screening. The study will be conducted in Veteran Affairs Medical Center and surrounding VA clinics in San Diego.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
775

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration 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, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

September 20, 2007

Last Update Submit

July 15, 2019

Conditions

Keywords

colon cancer screeningmail remindersfecal occult blood testcompliance

Outcome Measures

Primary Outcomes (1)

  • Our primary outcome is FOBT card return rate

    6 months

Secondary Outcomes (1)

  • Predictors of Non-compliance to fecal occult blood testing

    6 months

Study Arms (2)

1

EXPERIMENTAL

400 patients will be given a mailed educational reminder 10 days after picking up their FOBT cards from the VA laboratory.

Other: Mailed Educational Reminder

2

NO INTERVENTION

400 patients will not receive a mailed educational reminder to return their FOBT cards after they have picked up the FOBT cards from the VA laboratory

Interventions

1 page educational reminder that reminds the patient to return their FOBT cards back to the VA laboratory. In addition, it also contains reasons why colon cancer screening is important.

1

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • asymptomatic men and women age 50 years or older who received screening FOBT card kits from the laboratory

You may not qualify if:

  • are less than 50 years of age
  • are inpatients
  • are not undergoing routine colon cancer screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veteran Affairs Medical Center San Diego

San Diego, California, 92161, United States

Location

Related Publications (2)

  • Stokamer CL, Tenner CT, Chaudhuri J, Vazquez E, Bini EJ. Randomized controlled trial of the impact of intensive patient education on compliance with fecal occult blood testing. J Gen Intern Med. 2005 Mar;20(3):278-82. doi: 10.1111/j.1525-1497.2005.40023.x.

    PMID: 15836533BACKGROUND
  • Lee JK, Reis V, Liu S, Conn L, Groessl EJ, Ganiats TG, Ho SB. Improving fecal occult blood testing compliance using a mailed educational reminder. J Gen Intern Med. 2009 Nov;24(11):1192-7. doi: 10.1007/s11606-009-1087-5. Epub 2009 Sep 23.

MeSH Terms

Conditions

Colonic NeoplasmsPatient Compliance

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Samuel B Ho, M.D.

    UCSD, VA San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 24, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations