The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program
NCT ID: NCT01688817
Last Updated: 2012-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
2008-05-31
2010-05-31
Brief Summary
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Detailed Description
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To our best knowledge there are no randomized controlled trials, dedicated specifically to assess the effect of physician's counseling on participation rate in primary colonoscopy CRC screening programs. There is also no data on the impact of physician's counseling on patient's decision to choose unsedated (not in sedation) or sedated colonoscopy.
In this study we aimed to quantitatively estimate the impact of a PCP's counseling on screening participation rate and utilization of sedation in the opportunistic primary CRC screening program when compared to the effect obtained by using a standardized information leaflet only.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Physician's counseling
Physician's counseling
Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP. The issue was discussed during a routine medical visit according to a standardized scheme. PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease. A patient was told about colonoscopy-based screening program. A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation. According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.
Information leaflet
Information leaflet
Patients were given leaflet on primary colonoscopy colorectal cancer screening program. A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.
Interventions
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Physician's counseling
Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP. The issue was discussed during a routine medical visit according to a standardized scheme. PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease. A patient was told about colonoscopy-based screening program. A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation. According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.
Information leaflet
Patients were given leaflet on primary colonoscopy colorectal cancer screening program. A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* change in bowel habits in the previous six months
* a visible blood in stool (unless related to known hemorrhoids)
* anemia or weight loss of unknown cause
* severe comorbid conditions making subject ineligible for screening colonoscopy
50 Years
65 Years
ALL
No
Sponsors
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Centre of Postgraduate Medical Education
OTHER
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Jaroslaw Regula, MD, PhD
Role: STUDY_DIRECTOR
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Michal F. Kaminski, MD, PhD
Role: STUDY_CHAIR
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Michal Wiszniewski, MD
Role: PRINCIPAL_INVESTIGATOR
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
References
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Boguradzka A, Wiszniewski M, Kaminski MF, Kraszewska E, Mazurczak-Pluta T, Rzewuska D, Ptasinski A, Regula J. The effect of primary care physician counseling on participation rate and use of sedation in colonoscopy-based colorectal cancer screening program--a randomized controlled study. Scand J Gastroenterol. 2014 Jul;49(7):878-84. doi: 10.3109/00365521.2014.913191. Epub 2014 May 5.
Other Identifiers
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CMKP-2008
Identifier Type: -
Identifier Source: org_study_id