Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp

Colorectal Cancer Clinical Trial

Official title:

Improving Surveillance for Colorectal Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397969
• Other study ID #: CDR0000492752
• Secondary ID: HMS-M11837-103BW
• Status: Completed
• Phase: N/A
• First received: November 9, 2006
• Last updated: December 18, 2013
• Start date: February 2005
• Est. completion date: June 2008

Study information

• Verified date: December 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Receiving a reminder letter from their doctor may increase the frequency of colonoscopy in patients who have had a colorectal polyp removed.

PURPOSE: This randomized clinical trial is studying how well a reminder letter from their doctor improves the frequency of colonoscopy in patients who have had a colorectal polyp removed.

Description:

OBJECTIVES:

• Determine whether rates of surveillance colonoscopy can be substantially increased by linking computerized data on endoscopic screening procedures to computerized pathology data to identify patients with prior adenomatous polyps who are due for repeat colonoscopy.

• Evaluate whether the impact of the intervention varies by patient characteristics, including age, sex, or site of primary care.

OUTLINE: This is a randomized, controlled, crossover study. Patients are stratified according to age (≤ 65 years of age vs > 65 years of age), gender, time elapsed since last colonoscopy, and primary care physician's (PCP) membership in Harvard Vanguard Medical Associates (yes vs no). Patients are randomized to 1 of 2 arms.

• Arm I: PCPs are mailed response forms (regarding the disposition of their eligible patients [e.g. patient letter mailed, patient called, scheduled for colonoscopy, colonoscopy completed elsewhere, patient refused procedure, clinical contraindication, patient deceased]) and letters reminding them that their patients are due for a follow-up colonoscopy. PCPs who do not return response forms within 4 weeks are sent a second set of reminders and patient letters.

• Arm II: Six months after the beginning of the study, PCPs are mailed response forms and patient letters once. A second set of reminders and patient letters are not sent.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Prior diagnosis of adenomatous polyp

• Underwent prior colonoscopy with polypectomy at Brigham and Women's Hospital

• Due for repeat colonoscopy according to current national guidelines of the American Gastroenterology Association (no colonoscopy within the past 5 years)

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Colorectal Cancer
• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• counseling intervention

Procedure:
• screening colonoscopy

Locations

Country	Name	City	State
United States	Dana-Farber/Brigham and Women's Cancer Center	Boston	Massachusetts
United States	Harvard Medical School	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Medical School	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful completion of follow-up colonoscopy			No
Primary	Number of patients completing colonoscopy during the study period			No