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Completed

NCT Number: NCT01688817

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

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

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Key information

Conditions

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

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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).

    Time frame: Six months after intervention

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

  • Centre of Postgraduate Medical Education

Registry information

Official study title

The Magnitude of Effect of Physician's Counseling on Participation Rate and Utilization of Sedation in Colonoscopy-based Colorectal Cancer Screening Program

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Sep 20, 2012
Registry last updated
Sep 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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