Clinical trial NCT01688817: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Colorectal Neoplasms
Colonoscopy
Early Detection of Cancer
Patient Selection
Patient Participation
Physicians, Primary Care
Conscious Sedation
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
First posted: 2012-09-20
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program
timeFrame: Six months after intervention
Secondary outcomes:
measure: Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).
timeFrame: Six months after intervention
Other outcomes:
Locations:
Study officials:
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
name: Jaroslaw Regula, MD, PhD
role: STUDY_DIRECTOR
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
name: Michal F. Kaminski, MD, PhD
role: STUDY_CHAIR
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
name: Michal Wiszniewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.