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

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Other: Physician's counseling; Other: Information leaflet

Study type: Interventional

Funder types: Other

Identifiers

NCT01688817

CMKP-2008

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Physician's counseling

Other group

Treatment:

Other: Physician's counseling

Information leaflet

Active Comparator group

Treatment:

Other: Information leaflet