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

NCT01688817 | Completed

• 1 other identifier: CMKP-2008
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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

Conditions

Colorectal Neoplasms

Keywords

Colorectal Neoplasms; Colonoscopy; Early Detection of Cancer; Patient Selection; Patient Participation; Physicians, Primary Care; Conscious Sedation

Outcome Measures

Primary Outcomes (1)

• Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program

  Six months after intervention

Secondary Outcomes (1)

• Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).

  Six months after intervention

Study Arms (2)

Physician's counseling

OTHER

Other: Physician's counseling

Information leaflet

ACTIVE COMPARATOR

Other: Information leaflet

Interventions

Physician's counseling OTHER

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.

Physician's counseling

Information leaflet OTHER

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.

Information leaflet

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Centre of Postgraduate Medical Education: collaborator

Related Publications (1)

• 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.

  PMID: 24797871 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jaroslaw Regula, MD, PhD

  The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

  STUDY DIRECTOR

• Michal F. Kaminski, MD, PhD

  The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland

  STUDY CHAIR

• Michal Wiszniewski, MD

  The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2010
• Last Updated: September 26, 2012

Record last verified: 2012-09