The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program
The Magnitude of Effect of Physician's Counseling on Participation Rate and Utilization of Sedation in Colonoscopy-based Colorectal Cancer Screening Program
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Physician's counseling
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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.
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Actieve vergelijker: Information leaflet
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program
Tijdsspanne: Six months after intervention
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Six months after intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).
Tijdsspanne: Six months after intervention
|
Six months after intervention
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie directeur: Jaroslaw Regula, MD, PhD, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- Studie stoel: Michal F. Kaminski, MD, PhD, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
- Hoofdonderzoeker: Michal Wiszniewski, MD, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CMKP-2008
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