The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physician's counseling
Information leaflet
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Neoplasms focused on measuring Colorectal Neoplasms, Colonoscopy, Early Detection of Cancer, Patient Selection, Patient Participation, Physicians, Primary Care, Conscious Sedation
Eligibility Criteria
Inclusion Criteria:
- 50-65 years of age
Exclusion Criteria:
- colonoscopy within last 10 years
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Physician's counseling
Information leaflet
Arm Description
Outcomes
Primary Outcome Measures
Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program
Secondary Outcome Measures
Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).
Full Information
NCT ID
NCT01688817
First Posted
September 17, 2012
Last Updated
September 24, 2012
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education
1. Study Identification
Unique Protocol Identification Number
NCT01688817
Brief Title
The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program
Official Title
The Magnitude of Effect of Physician's Counseling on Participation Rate and Utilization of Sedation in Colonoscopy-based Colorectal Cancer Screening Program
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the impact of physician's counseling on participation and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening program
Detailed Description
Participation rate is one of the major factors influencing the effectiveness of screening programs. Participation rates in CRC screening, including primary colonoscopy programs, remain suboptimal. It is known that one of the strongest predictors of CRC screening participation rate is a physician, especially primary care physician (PCP), recommendation. Engaging a PCP tends to improve participation rate in organized and opportunistic cancer screening programs.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colorectal Neoplasms, Colonoscopy, Early Detection of Cancer, Patient Selection, Patient Participation, Physicians, Primary Care, Conscious Sedation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physician's counseling
Arm Type
Other
Arm Title
Information leaflet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Physician's counseling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Information leaflet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program
Time Frame
Six months after intervention
Secondary Outcome Measure Information:
Title
Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).
Time Frame
Six months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
50-65 years of age
Exclusion Criteria:
colonoscopy within last 10 years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Regula, MD, PhD
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michal F. Kaminski, MD, PhD
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michal Wiszniewski, MD
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24797871
Citation
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.
Results Reference
derived
Learn more about this trial
The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program
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