- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00929097
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer (RISCO)
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Regular colonoscopy is effective in reducing morbidity and mortality due to colorectal cancer (CRC) in patients at increased familial CRC risk. Currently, the majority of these at-risk individuals are not properly referred for increased surveillance by colonoscopy or genetic counselling. In 2008, a national multidisciplinary evidence-based guideline on familial and hereditary CRC was launched in the Netherlands. Clinicians have new tasks in familial CRC risk calculation, interpretation and communication. A clustered randomized controlled trial including an effect, process and cost evaluation will be conducted in eighteen Dutch hospitals to determine the most cost effective way to implement these new guidelines.
Surgeons and gastroenterologists in both the intervention group and the control group will receive background information on familial colorectal cancer risk and the guidelines. Patients and clinicians in the intervention group will receive an additional intervention strategy.
The effect evaluation is done by assessing the number of CRC patients for whom correct risk calculation, interpretation and communication is performed, as well as patients' uptake of the recommended follow up policy. The actual exposure to the different elements of the implementation procedure and the experiences of users will be assessed in the process evaluation. The costs of the implementation procedure will be determined by means of a cost evaluation.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of colorectal cancer before the age of 70
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Exclusion Criteria:
- Previous referral for genetic counseling
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Styre
|
Dissemination of guidelines
|
Eksperimentell: Implementation aids
|
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The number of patients for whom MSI testing was performed based on the MIPA criteria
Tidsramme: 1 year
|
1 year
|
The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks)
Tidsramme: 1 year
|
1 year
|
The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
Tidsramme: 1 year
|
1 year
|
The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians
Tidsramme: 1 year
|
1 year
|
Patients' uptake of the follow up policy
Tidsramme: 1 year
|
1 year
|
Actual exposure to the different elements of the implementation strategy
Tidsramme: 1 year
|
1 year
|
Experiences of clinicians and patients with the different elements of the implementation strategy
Tidsramme: 1 year
|
1 year
|
Costs of the implementation procedure
Tidsramme: 1 year
|
1 year
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nicoline Hoogerbrugge, MD, PhD, Radboud University Medical Center
- Hovedetterforsker: Rosella PMG Hermens, PhD, Radboud University Medical Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Dekker N, Hermens RP, Nagengast FM, van Zelst-Stams WA, Hoogerbrugge N; RISCO study group. Familial colorectal cancer risk assessment needs improvement for more effective cancer prevention in relatives. Colorectal Dis. 2013 Apr;15(4):e175-85; discussion p.e185. doi: 10.1111/codi.12117.
- Dekker N, Hermens RP, Elwyn G, van der Weijden T, Nagengast FM, van Duijvendijk P, Salemink S, Adang E, van Krieken JH, Ligtenberg MJ, Hoogerbrugge N. Improving calculation, interpretation and communication of familial colorectal cancer risk: protocol for a randomized controlled trial. Implement Sci. 2010 Jan 28;5:6. doi: 10.1186/1748-5908-5-6.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Metabolske sykdommer
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Genetiske sykdommer, medfødte
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Neoplastiske syndromer, arvelig
- DNA-reparasjon-mangellidelser
- Kolorektale neoplasmer
- Kolorektale neoplasmer, arvelig ikke-polypose
Andre studie-ID-numre
- ZonMw 80-82315-98-09005
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