ClinicalTrials.gg
CompletedNCT00436137Updated Nov 6, 2008

Improving Followup of Abnormal Colon Cancer Screening Tests

An interventional study of Patient mailing in Colorectal Cancer, sponsored by Harvard Vanguard Medical Associates. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-11-06.

Sponsored by Harvard Vanguard Medical Associates · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether direct mailings to patients with positive fecal occult blood tests can increase rates of performing followup colonoscopy.

Read the detailed description

Screening programs using the fecal occult blood test (FOBT) have demonstrated a significant reduction in colorectal cancer mortality, although only when accompanied by a complete diagnostic evaluation of the colon in the setting of a positive result. 90% of patients with a positive FOBT result have completed a subsequent colonoscopy within Harvard Vanguard Medical Associates. This project will use a pre-post study design to increase the rate of followup colonoscopy in the setting of positive FOBT results. Patients in the intervention group will receive a personalized mailing highlighting their positive result and need for colonoscopy, followed by telephone outreach from a centralized gastroenterology scheduling office. The primary outcome will be the performance of colonoscopy, however we will also perform chart reviews to identify predictors of completing appropriate followup.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Colorectal cancer
  • Fecal occult blood test
  • Abnormal test result
  • Missed diagnosis
  • Delayed diagnosis
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's enrollment of 70 is close to the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Harvard Vanguard Medical Associates is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with positive fecal occult blood test during 2004, 2005, and 2006; and no colonoscopy following this test result

Exclusion criteria

Exclusion Criteria:

  • Patients with active cardiopulmonary disease or limited life expectancy due to severe illness such as malignancy
  • Colonoscopy within 5 years prior to positive fecal occult blood test
  • Age > 80 years
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    1

    Patients will receive a mailing recommending colonoscopy, followed by a telephone outreach

    Behavioral: Patient mailing

Interventions

  • BehavioralPatient mailing

    Patient will receive a mailing recommending colonoscopy, followed by telephone outreach

06

What researchers measure

Primary outcomes

  1. Performance of colonoscopy

    Time frame: 6 months

07

Study locations

1 site
  • Harvard Vanguard Medical Associates
    Newton, Massachusetts 02466, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2007, a primary completion of Mar 2008 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2007
First posted
Feb 16, 2007
Start
Jun 2007
Primary completionActual
Mar 2008
CompletionActual
Mar 2008
Last update
Nov 6, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00436137
Lead sponsor
Harvard Vanguard Medical Associates
First posted
Feb 16, 2007
Start date
Jun 2007
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Nov 6, 2008

Study contacts

Thomas D Sequist, MD, MPH
principal investigator · Harvard Vanguard Medical Associates

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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