- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Kontrollera
|
Dissemination of guidelines
|
|
Experimentell: Implementation aids
|
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
Tidsram: 1 year
|
1 year
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The number of patients for whom MSI testing was performed based on the MIPA criteria
Tidsram: 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)
Tidsram: 1 year
|
1 year
|
|
The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
Tidsram: 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
Tidsram: 1 year
|
1 year
|
|
Patients' uptake of the follow up policy
Tidsram: 1 year
|
1 year
|
|
Actual exposure to the different elements of the implementation strategy
Tidsram: 1 year
|
1 year
|
|
Experiences of clinicians and patients with the different elements of the implementation strategy
Tidsram: 1 year
|
1 year
|
|
Costs of the implementation procedure
Tidsram: 1 year
|
1 year
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Nicoline Hoogerbrugge, MD, PhD, Radboud University Medical Center
- Huvudutredare: Rosella PMG Hermens, PhD, Radboud University Medical Center
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Metaboliska sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Genetiska sjukdomar, medfödda
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Neoplastiska syndrom, ärftligt
- DNA-reparation-briststörningar
- Kolorektala neoplasmer
- Kolorektala neoplasmer, ärftlig icke-polypos
Andra studie-ID-nummer
- ZonMw 80-82315-98-09005
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .