NCT00436137

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable colorectal-cancer

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

First Submitted

Initial submission to the registry

February 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

November 6, 2008

Status Verified

November 1, 2008

Enrollment Period

9 months

First QC Date

February 14, 2007

Last Update Submit

November 5, 2008

Conditions

Colorectal Cancer

Keywords

Colorectal cancerFecal occult blood testAbnormal test resultMissed diagnosisDelayed diagnosis

Outcome Measures

Primary Outcomes (1)

  • Performance of colonoscopy

    6 months

Study Arms (1)

1

EXPERIMENTAL

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

Behavioral: Patient mailing

Interventions

Patient mailingBEHAVIORAL

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

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Vanguard Medical Associates

Newton, Massachusetts, 02466, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Thomas D Sequist, MD, MPH

    Harvard Vanguard Medical Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 16, 2007

Study Start

June 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 6, 2008

Record last verified: 2008-11

Locations

US(1)