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

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Other: Physician's counseling; Other: Information leaflet

• Registration Number: NCT01688817
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-12
• Study Completion: 2010-05
• Status Verified: 2012-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-20
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• 50-65 years of age

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physician's counseling	Physician's counseling	-
Information leaflet	Information leaflet	-

Primary Outcome Measures

Name	Time	Method
Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program	Six months after intervention

Secondary Outcome Measures

Name	Time	Method
Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).	Six months after intervention