Colon CancerNCT03682133
PreColo Practice Variation
An observational study of Colon Cancer and Aging, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
This study will answer the question what the practice variation is (in terms of efficiency) in primary colon surgery on patients of 75 years and above related to the application of different modalities of prehabilitation across the Netherlands. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Colon Cancer, Aging, Postoperative Complications
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- 27 Jun 2018to 1 Jul 2019
- How long will I take part?
- 3 Months
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Outpatients from the participating hospitals
Who may be able to join
- Patients aged 75 years and above
- Scheduled for colon cancer surgery
Who cannot join
- Not receiving surgery
- Hematogenous metastasis
- Pretreatment; chemotherapy or radiotherapy
- Rectal cancer
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Gelre ziekenhuizen
Apeldoorn, Gelderland, 7334 DZ
Radboudumc
Nijmegen, Gelderland, 6525 GA
About this study
Official title: Practice Variation in Colon Cancer Surgery Care in Older Patients
This study will answer the question what the practice variation is (in terms of efficiency) in primary colon surgery on patients of 75 years and above related to the application of different modalities of prehabilitation across the Netherlands.
Read the detailed description
Rationale: Prehabilitation has shown promising results in orthopedic, cardiothoracic and abdominal surgery. However, there is still a lack of data supporting cost-effectiveness of prehabilitation in colon cancer surgery in older patients. Therefore the Dutch guidelines still restrict prehabilitation for research settings.
Objective: This study will answer the question what the practice variation is (in terms of efficiency) in primary colon surgery on patients of 75 years and above related to the application of different modalities of prehabilitation across the Netherlands. Besides, it will show what service factors (including prehabilitation) determine the technical efficiency of primary colon surgery for these patients of 75 years and above.
Study design: This study is a multicenter observational study based on questionnaires and existing data sources, aimed at including 24 different hospitals, of which structural, process and outcome data related to prehabilitation and colon cancer surgery will be registered.
Study population: Patients aged 75 years and above, 10 per participating hospital, who underwent colon cancer surgery in one of the participating hospitals, where prehabilitation is or is not applied. All patients will be followed with questionnaires focusing on process and outcome measures for the hospital period and three months after discharge.
Intervention: Whether or not the intervention (prehabilitation) is judged as part of daily practice in a participating hospital is based on a predefined definition of oncological surgical prehabilitation. The care as given in a participating hospital is according to the local guideline and will not be changed for this study. According to our definition prehabilitation consists at least of a minimum of 2 weeks exercise therapy and a review of the patients nutritional status at least 2 weeks before surgery.
Usual care: Guideline based colon cancer surgery, without prehabilitation. Main study endpoints: Technical efficiency and service factors that determine this technical efficiency of primary colon cancer surgery. The results will be presented anonymously both for patients and hospitals (so there will not be carried out benchmark analyses per center).
Statistical analysis: Data Envelopment Analysis will be carried out. Factors that might explain variability in technical efficiency will be regressed on bias corrected DEA scores (via truncated regression). Ethical considerations: There will be no change in standard procedures in everyday care. The burden for participants is minimal.
- Conditions
- Colon Cancer, Aging, Postoperative Complications
- Keywords
- Prehabilitation, Preoperative care
- Medical subject headings
- Colonic Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | The care as given in a participating hospital is according to the local guideline and will not be changed for this study. Whether prehabilitation is applied in a participating hospital is based on a predefined definition of oncological surgical prehabilitation. | |
| Usual care | Guideline based colon cancer surgery, without prehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical efficiency measured using Data Envelopment Analysis (DEA)
Multiple measurements will be aggregated to arrive at one reported value; technical efficiency. Measurements will be invested care, length of stay, mortality, complication rate and PROMs.
Measured: up to 4 months
Truncated logistic regression analysis
Truncated regression analysis will be performed to identify which explanatory variable(s) predict technical efficiency. Possible explanatory variables will be casemix, yes/ no availability of shared care with geriatrics, yes/no availability of prehabilitation in unimodal or multimodal version, mean volume of older colon cancer patients per practice, propensity score for the frailty of the case mix based on age/sex/disabilities, yes/no availability of laparoscopic colon cancer surgery.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start27 Jun 2018
- Primary completion1 Mar 2019
- Study completion1 Jul 2019
Why it stopped: Retrospective part completed, prospective part response too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Leading the Change; Zorgverzekaars Nederland
- Responsible party
- Sponsor
- Investigators
- Marcel GM Olde Rikkert, Prof. dr., Principal investigator, Radboud University Medical CenterHans HW de Wilt, Prof. dr., Study chair, Radboud University Medical CenterThea C Heil, Msc., Principal investigator, Radboud University Medical CenterBarbara C. van Munster, Dr., Study chair, Gelre HospitalsRené JF Melis, Dr., Study chair, Radboud University Medical CenterHuub AA Maas, Dr., Study chair, ETZPeter van Duijvendijk, Dr., Study chair, Gelre Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682133
- Sponsor's protocol ID
- PreColo PV
- Status last verified
- May 2018
- First submitted
- 24 Jul 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Variation in Colon Cancer Surgery Care in Older Patients
- ClinicalTrials.gov ID
- NCT03682133
- Acronym / sponsor ID
- PreColo PV
- Conditions
- Colon Cancer, Aging, Postoperative Complications
- Keywords
- Prehabilitation, Preoperative care
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Retrospective part completed, prospective part response too low
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Leading the Change; Zorgverzekaars Nederland
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 24 Sep 2018 (actual)
- 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.
This study will answer the question what the practice variation is (in terms of efficiency) in primary colon surgery on patients of 75 years and above related to the application of different modalities of prehabilitation across the Netherlands.
Detailed description
Rationale: Prehabilitation has shown promising results in orthopedic, cardiothoracic and abdominal surgery. However, there is still a lack of data supporting cost-effectiveness of prehabilitation in colon cancer surgery in older patients. Therefore the Dutch guidelines still restrict prehabilitation for research settings.
Objective: This study will answer the question what the practice variation is (in terms of efficiency) in primary colon surgery on patients of 75 years and above related to the application of different modalities of prehabilitation across the Netherlands. Besides, it will show what service factors (including prehabilitation) determine the technical efficiency of primary colon surgery for these patients of 75 years and above.
Study design: This study is a multicenter observational study based on questionnaires and existing data sources, aimed at including 24 different hospitals, of which structural, process and outcome data related to prehabilitation and colon cancer surgery will be registered.
Study population: Patients aged 75 years and above, 10 per participating hospital, who underwent colon cancer surgery in one of the participating hospitals, where prehabilitation is or is not applied. All patients will be followed with questionnaires focusing on process and outcome measures for the hospital period and three months after discharge.
Intervention: Whether or not the intervention (prehabilitation) is judged as part of daily practice in a participating hospital is based on a predefined definition of oncological surgical prehabilitation. The care as given in a participating hospital is according to the local guideline and will not be changed for this study. According to our definition prehabilitation consists at least of a minimum of 2 weeks exercise therapy and a review of the patients nutritional status at least 2 weeks before surgery.
Usual care: Guideline based colon cancer surgery, without prehabilitation. Main study endpoints: Technical efficiency and service factors that determine this technical efficiency of primary colon cancer surgery. The results will be presented anonymously both for patients and hospitals (so there will not be carried out benchmark analyses per center).
Statistical analysis: Data Envelopment Analysis will be carried out. Factors that might explain variability in technical efficiency will be regressed on bias corrected DEA scores (via truncated regression). Ethical considerations: There will be no change in standard procedures in everyday care. The burden for participants is minimal.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | – | –The care as given in a participating hospital is according to the local guideline and will not be changed for this study. Whether prehabilitation is applied in a participating hospital is based on a predefined definition of oncological surgical prehabilitation. |
| Usual care | – | –Guideline based colon cancer surgery, without prehabilitation. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Outpatients from the participating hospitals
Key inclusion criteria (2 listed)
- Patients aged 75 years and above
- Scheduled for colon cancer surgery
Key exclusion criteria (4 listed)
- Not receiving surgery
- Hematogenous metastasis
- Pretreatment; chemotherapy or radiotherapy
- Rectal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical efficiency measured using Data Envelopment Analysis (DEA)
Time frame: up to 4 months
Multiple measurements will be aggregated to arrive at one reported value; technical efficiency. Measurements will be invested care, length of stay, mortality, complication rate and PROMs.
Truncated logistic regression analysis
Time frame: up to 4 months
Truncated regression analysis will be performed to identify which explanatory variable(s) predict technical efficiency. Possible explanatory variables will be casemix, yes/ no availability of shared care with geriatrics, yes/no availability of prehabilitation in unimodal or multimodal version, mean volume of older colon cancer patients per practice, propensity score for the frailty of the case mix based on age/sex/disabilities, yes/no availability of laparoscopic colon cancer surgery.
Results and safety
The study was stopped early (reason given: Retrospective part completed, prospective part response too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Marcel GM Olde Rikkert, Prof. dr. principal investigator
Radboud University Medical Center
Hans HW de Wilt, Prof. dr. study chair
Radboud University Medical Center
Thea C Heil, Msc. principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Aging, run by Radboud University Medical Center at 2 sites in Netherlands.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 was stopped early (reason given: Retrospective part completed, prospective part response too low). Results are not available in the source record.
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?
Technical efficiency measured using Data Envelopment Analysis (DEA) (time frame: up to 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2019.