Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to improve clinicians' calculation, interpretation and communication of familial colorectal cancer risk, as well as patients' risk perception and uptake of referral for genetic counselling or for surveillance by colonoscopy for their relatives at risk.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementation of a New Strategy to Identify HNPCC Patients

NCT00141466

Colorectal Neoplasms Hereditary Nonpolyposis Colorectal Cancer

UNKNOWN NA

Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer

NCT00675636

Colorectal Cancer Hereditary Non-polyposis Colon Cancer Precancerous Condition

COMPLETED

Follow-up After Surgery for Colorectal Cancer

NCT05656326

Colorectal Cancer Quality of Life

ACTIVE_NOT_RECRUITING

Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

NCT00582829

Colorectal Cancer Screening +1 more

COMPLETED

A Program for Improved Family Screening for Colorectal Cancer

NCT03620877

Colorectal Cancer

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Neoplasms, Hereditary Nonpolyposis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Implementation aids

Group Type EXPERIMENTAL

Implementation aids

Intervention Type OTHER

* Patients and clinicians have access to a website with information on familial colorectal cancer risk; a risk assessment tool and decision aids
* Clinicians receive the guidelines and a risk communication tool, as well as education

Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Dissemination of guidelines

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implementation aids

* Patients and clinicians have access to a website with information on familial colorectal cancer risk; a risk assessment tool and decision aids
* Clinicians receive the guidelines and a risk communication tool, as well as education

Intervention Type OTHER