- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02965794
Care Pathways for Colorectal Cancer Surgery (CP4GICAN)
January 27, 2020 updated by: Dr. Kris Vanhaecht, European Pathway Association
Descriptive Study to Evaluate the Care Process and the Quality of Care for Adult Cancer Patients Who Are Admitted for Colorectal Cancer Surgery.
EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This descriptive study uses an interrupted time series approach combining a retrospective with a prospective multicenter design to evaluate the current state of the care process for adult colorectal cancer patients who are admitted for surgery.
This study will give attention to evidence based key interventions, follow-up and interprofessional teamwork necessary to provide appropriate care.
In 4 countries (Belgium, Germany, France and The Netherlands) 3 hospitals will participate (total number of hospitals is 12).
They will perform a clinical audit of the actual organization of the care process, and a team audit on the level of interprofessional teamwork.
Each team will develop and implement a quality improvement initiative based on the concept of care pathways, the findings from the audit and the available evidence, and will measure the effect of their improvement strategy.
Study Type
Observational
Enrollment (Actual)
480
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leuven, Belgium, 3000
- KULeuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults undergoing surgery for colorectal cancer
Description
Inclusion Criteria:
- All consecutive scheduled admissions starting September 2, 2013;
- Minimum age of 18 years;
- Elective admission for colorectal cancer surgery
Exclusion Criteria:
- Emergency (not planned) admission for colorectal cancer surgery;
- Patients with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Usual care
quality of care will be measured in the participating hospitals, using a retrospective patient record analysis
|
|
|
Care Pathway
Care pathways for colorectal cancer
|
development of a care pathway for this patient group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay
Time Frame: through study completion, an average of 4 months
|
Number of days in hospital
|
through study completion, an average of 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to return to normal diet
Time Frame: through study completion, an average of 4 months
|
number of days in between surgery and day of normal diet
|
through study completion, an average of 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kris Vanhaecht, PhD, KU Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
November 1, 2019
Study Registration Dates
First Submitted
August 4, 2014
First Submitted That Met QC Criteria
November 16, 2016
First Posted (Estimate)
November 17, 2016
Study Record Updates
Last Update Posted (Actual)
January 28, 2020
Last Update Submitted That Met QC Criteria
January 27, 2020
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP4NutriGICAN2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Yale UniversityNational Institute of Nursing Research (NINR); The Glimpse Group IncRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
University of Michigan Rogel Cancer CenterCompletedCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); Atrium Health Wake Forest BaptistRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
Vanderbilt-Ingram Cancer CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Second Affiliated Hospital of Soochow UniversityNot yet recruitingCancer | Solid Cancer
-
New Mexico Cancer Research AllianceOhio State University Comprehensive Cancer Center; H. Lee Moffitt Cancer Center...RecruitingCancer | Cancer RiskUnited States
-
Children's Hospital of PhiladelphiaCompletedCancer | Childhood CancerUnited States
-
UNICANCERRecruitingAdvanced Breast Cancer | Advanced Gastric Cancer | Advanced Urothelial Cancer | Advanced Non Small Cell Lung Cancer (NSCLC)France
Clinical Trials on Care pathways for colorectal cancer
-
Maria Sklodowska-Curie National Research Institute...Centre of Postgraduate Medical Education; Ministry of Health, PolandUnknown
-
Sun Yat-sen UniversityUnknown
-
US Department of Veterans AffairsCompleted
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)CompletedFemoral Fractures | Hip FracturesCanada
-
G. Hatzikosta General HospitalUniversity of IoanninaCompletedColorectal Cancer | Oxidative Stress | Colon Rectal ResectionGreece
-
University of BolognaRecruitingColorectal Neoplasms MalignantItaly
-
Sahlgrenska University Hospital, SwedenRecruitingColorectal NeoplasmsSweden
-
Virginia Commonwealth UniversityBlue Cross Blue Shield; Allina Health SystemCompletedColorectal Cancer Screening | Shared Decision MakingUnited States
-
Dong PengActive, not recruitingColorectal Cancer | Metabolic DiseaseChina
-
George Washington UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Not yet recruiting