CancerCP4GICANNCT02965794
Care Pathways for Colorectal Cancer Surgery
An observational study of Cancer, run by European Pathway Association at 1 site in Belgium.
Trial summary
EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Care pathways for colorectal cancer
- How many people
- 480 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults undergoing surgery for colorectal cancer
Who may be able to join
- All consecutive scheduled admissions starting September 2, 2013;
- Minimum age of 18 years;
- Elective admission for colorectal cancer surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Cancer
- Being tested
- Care pathways for colorectal cancer
- Keywords
- surgery, bowel, rectum, cancer, nutrition
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care pathways for colorectal cancerOther
Also called care pathway, clinical pathway, critical pathway
development of a care pathway for this patient group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Care pathways for colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Number of days in hospital
Measured: through study completion, an average of 4 months
Secondary outcomes (1)
Time to return to normal diet
number of days in between surgery and day of normal diet
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Pathway Association
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Dr. Kris Vanhaecht, European Pathway Association
- Investigators
- Kris Vanhaecht, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965794
- Sponsor's protocol ID
- CP4NutriGICAN2014
- Acronym
- CP4GICAN
- Status last verified
- Jan 2019
- First submitted
- 4 Aug 2014
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
van Zelm R, Coeckelberghs E, Sermeus W, Wolthuis A, Bruyneel L, Panella M, Vanhaecht K. A mixed methods multiple case study to evaluate the implementation of a care pathway for colorectal cancer surgery using extended normalization process theory. BMC Health Serv Res. 2021 Jan 4;21(1):11. doi: 10.1186/s12913-020-06011-w.
PubMed 33397382
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study to Evaluate the Care Process and the Quality of Care for Adult Cancer Patients Who Are Admitted for Colorectal Cancer Surgery.
- ClinicalTrials.gov ID
- NCT02965794
- Acronym / sponsor ID
- CP4GICAN / CP4NutriGICAN2014
- Conditions
- Cancer
- Keywords
- surgery, bowel, rectum, cancer, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- European Pathway AssociationUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Oct 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | – | –quality of care will be measured in the participating hospitals, using a retrospective patient record analysis |
| Care Pathway | – | Other: Care pathways for colorectal cancerCare pathways for colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing surgery for colorectal cancer
Key inclusion criteria (3 listed)
- All consecutive scheduled admissions starting September 2, 2013;
- Minimum age of 18 years;
- Elective admission for colorectal cancer surgery
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care pathways for colorectal cancerAlso: care pathway, clinical pathway, critical pathwaydevelopment of a care pathway for this patient group | Other | Care Pathway |
Primary outcome
Length of stay
Time frame: through study completion, an average of 4 months
Number of days in hospital
1 secondary outcome
Time to return to normal diet
Time frame: through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 33397382van Zelm R, Coeckelberghs E, Sermeus W, Wolthuis A, Bruyneel L, Panella M, Vanhaecht K. A mixed methods multiple case study to evaluate the implementation of a care pathway for colorectal cancer surgery using extended normalization process theory. BMC Health Serv Res. 2021 Jan 4;21(1):11. doi: 10.1186/s12913-020-06011-w.
- Individual participant dataSharing planned: No
Related trials for Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Vanhaecht, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by European Pathway Association at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.