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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
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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

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    The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program

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