Reminding Patients of the Important of Colorectal Cancer Screening Results in Patient-Initiated Promoting Colorectal Cancer Screening Via Colonoscopy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Oklahoma

ClinicalTrials.gov Identifier:

NCT01526239

First received: January 3, 2012

Last updated: February 2, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 3, 2012
Last Updated Date	February 2, 2012
Start Date ^ICMJE	November 2008
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 2, 2012)	Communication with primary care physicians about CRC screening [ Time Frame: 2 years ] [ Designated as safety issue: No ] The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01526239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Reminding Patients of the Important of Colorectal Cancer Screening Results in Patient-Initiated Promoting Colorectal Cancer Screening Via Colonoscopy
Official Title ^ICMJE	Patient-Reminder Results in Patient-Initiated Promoting Colorectal Cancer Screening Via Colonoscopy
Brief Summary	Colorectal cancer is the third most common cancer diagnosed and third leading cause of cancer-related deaths in the United States for both men and women. The American Cancer Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of rectal cancer will be diagnosed, and about 49,960 deaths will occur as a result of this devastating disease in 2008. Over the last 20 years, the death rate for this cancer has been dropping as a result of screening and early detection of cancer. In 2007, ACS reported that early-stage colorectal cancer had a survival rate close to 80%, and up to 9,632 deaths could be prevented each year if eligible patients received screening when necessary. However, despite the proven efficacy of colorectal cancer (CRC) screening, only about 50% of eligible US patients are currently being screened. Specific Aims The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening. The following three areas will be investigated during this research: To determine whether a communication tool provided to patients will initiate a conversation with their primary care physicians about CRC screening, especially via colonoscopy. To determine whether this tool will impact referral patterns for screening, especially, although not primarily, among poor and underserved populations. To determine whether differences exist in regard to patient-physician communication patterns about screening among residents and faculties in the fields of internal medicine and family practice clinics. At the close of the investigators study, the investigators wish to organize quantifiable data demonstrating how patient-initiated prompting of primary care physicians for CRC screening increases early detection and decreases potential mortality from colorectal cancer. This data will inform a second, larger study to pursue the questions surrounding patient-initiated prompting in
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Screening
Condition ^ICMJE	Colon Cancer
Intervention ^ICMJE	Other: Colorectal cancer screening pamphlet Colorectal cancer screening pamphlet
Study Arm (s)	Experimental: Intervention group Intervention consisted of a pamphlet about the benefit of CRC-S, given to patients prior to their PCP visit and a reminder note about CRC screening to be given to their physician during the encounter. Intervention: Other: Colorectal cancer screening pamphlet No Intervention: Control group Control group will not receive the pamphlet regarding colorectal cancers.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	274
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: All patient age older than 50, exception for African American age 45 and older
Gender	Both
Ages	45 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01526239
Other Study ID Numbers ^ICMJE	14225
Has Data Monitoring Committee	Yes
Responsible Party	University of Oklahoma
Study Sponsor ^ICMJE	University of Oklahoma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Oklahoma
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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