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CompletedNCT00397969Updated Dec 19, 2013

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

An interventional study of counseling intervention and screening colonoscopy in Colorectal Cancer and Precancerous Condition, sponsored by Harvard Medical School (HMS and HSDM). Completed at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-12-19.

Sponsored by Harvard Medical School (HMS and HSDM) · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
21 Years and older
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Colorectal Cancer
  • Precancerous Condition

Keywords

  • colon cancer
  • rectal cancer
  • precancerous condition
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In context

Precancerous Conditions

254 studies on the registry are indexed under Precancerous Conditions; 28 are open to participants now.

This study's planned enrollment of 800 is above the median of 60 across 163 interventional studies indexed under Precancerous Conditions.

Browse Precancerous Conditions studies →

Lead sponsor

Harvard Medical School (HMS and HSDM) is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

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

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Not applicable
Allocation
Randomized
Enrollment
800 participants (estimated)

Interventions

  • Othercounseling intervention
  • Procedurescreening colonoscopy
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What researchers measure

Primary outcomes

  1. Successful completion of follow-up colonoscopy

  2. Number of patients completing colonoscopy during the study period

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Study locations

2 sites
  • Dana-Farber/Brigham and Women's Cancer Center
    Boston, Massachusetts 02115, United States
  • Harvard Medical School
    Boston, Massachusetts 02115, United States
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References and documents

Publications

  • Ayanian JZ, Sequist TD, Zaslavsky AM, Johannes RS. Physician reminders to promote surveillance colonoscopy for colorectal adenomas: a randomized controlled trial. J Gen Intern Med. 2008 Jun;23(6):762-7. doi: 10.1007/s11606-008-0576-2. Epub 2008 Apr 2. PubMed 18386103 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00397969
Lead sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Cancer Institute (NCI)
First posted
Nov 10, 2006
Start date
Feb 2005
Completion
Jun 2008
Last update
Dec 19, 2013

Study contacts

John Ayanian, MD, MPP
study chair · Harvard Medical School (HMS and HSDM)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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