Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-30 @ 8:02 PM
Study NCT ID:
NCT00397969
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2006-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2006-11-09', 'studyFirstSubmitQcDate': '2006-11-09', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful completion of follow-up colonoscopy'}, {'measure': 'Number of patients completing colonoscopy during the study period'}]}, 'conditionsModule': {'keywords': ['colon cancer', 'rectal cancer', 'precancerous condition'], 'conditions': ['Colorectal Cancer', 'Precancerous Condition']}, 'referencesModule': {'references': [{'pmid': '18386103', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Receiving a reminder letter from their doctor may increase the frequency of colonoscopy in patients who have had a colorectal polyp removed.\n\nPURPOSE: 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.', 'detailedDescription': "OBJECTIVES:\n\n* 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.\n* Evaluate whether the impact of the intervention varies by patient characteristics, including age, sex, or site of primary care.\n\nOUTLINE: 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.\n\n* 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.\n* 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.\n\nPROJECTED ACCRUAL: A total of 800 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Prior diagnosis of adenomatous polyp\n* Underwent prior colonoscopy with polypectomy at Brigham and Women's Hospital\n\n * Due for repeat colonoscopy according to current national guidelines of the American Gastroenterology Association (no colonoscopy within the past 5 years)\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics"}, 'identificationModule': {'nctId': 'NCT00397969', 'briefTitle': 'Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Improving Surveillance for Colorectal Polyps', 'orgStudyIdInfo': {'id': 'CDR0000492752'}, 'secondaryIdInfos': [{'id': 'HMS-M11837-103'}, {'id': 'BWH-2005-P-000371/3'}, {'id': 'HPHC-1705'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'counseling intervention', 'type': 'OTHER'}, {'name': 'screening colonoscopy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Dana-Farber/Brigham and Women's Cancer Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'John Ayanian, MD, MPP', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}