Colorectal CancerPreColo CUNCT04097795
Incremental Cost-Utility Study on Prehabilitation Among Older Patients With Colorectal Cancer Undergoing Surgery
An observational study of Colorectal Cancer and Surgery, run by Radboud University Medical Center at 5 sites in Netherlands.
Trial summary
A prospective multicenter observational cost-utility study following older or high-risk patients with colorectal cancer with and without prehabilitation before surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Surgery
- What is being tested?
- Prehabilitation
- How many people
- 72 participants
- Where
- 5 sitesNetherlands
- Study dates
- 1 Jul 2019to 31 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 70 years and above or patients with an ASA III score who are diagnosed with colorectal cancer and are scheduled for surgery as primary intervention will be recruited in the outpatient clinic of the surgery department of the participating hospitals.
Who may be able to join
- Age ≥ 70 years or American Society of Anesthesiologists (ASA) score of III
- Scheduled for colorectal cancer surgery
Who cannot join
- Metastatic disease known preoperatively
- ASA IV score or higher
- Paralytic or immobilized patients (not capable to perform exercise)
- Prior use of neoadjuvant therapy for the same indication
- Not able or willing to provide written informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Noordwest Ziekenhuisgroep
Alkmaar
Ziekenhuisgroep Twente
Almelo
Radboudumc
Nijmegen
Streekziekenhuis Koningin Beatrix
Winterswijk
About this study
Official title: Incremental Cost-utility Study on Prehabilitation for Colon Cancer Surgery in Older Patients
A prospective multicenter observational cost-utility study following older or high-risk patients with colorectal cancer with and without prehabilitation before surgery.
Read the detailed description
This study will answer the question whether prehabilitation is cost-effective in colorectal cancer surgery among individual patients aged 70 years and above or patients with an American Society of Anesthesiologists (ASA) score of III. We also aim to identify factors facilitating or impairing implementation of prehabilitation such that it is cost-effective.
- Conditions
- Colorectal Cancer, Surgery
- Being tested
- Prehabilitation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
According to our definition, prehabilitation consists of exercise therapy during at least 2 weeks. This is combined with optimalisation of the patients' nutritional status at least 2 weeks before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Patients aged 70 years and above or with an American Society of Anesthesiologists (ASA) score of III, who are scheduled for colorectal cancer surgery in one of the participating hospitals which offer prehabilitation. Receives: Other: Prehabilitation | |
| No prehabilitation | Patients aged 70 years and above or with an American Society of Anesthesiologists (ASA) score of III, who are scheduled for colorectal cancer surgery in one of the participating hospitals which do not offer prehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D-5L
Quality of life according to the EuroQol-5 dimensions-5 levels questionnaire. The 5 dimensions cover mobility, selfcare, daily activities, pain/discomfort and anxiety. All dimensions are rated on a 5 level scale ranging from 'I have no problems with ....(dimension)' to 'I am not able to/I am extremely...(dimension)'. The first option is considered 'better' and the latter as 'worse'.
Measured: 0-6 months
Costs
From a societal perspective including health care consumption costs, patient out-of-pocket costs, and productivity losses of informal caregivers
Measured: 0-6 months
Secondary outcomes (6)
Number of deceased patients
Data on mortality will be assessed based on medical records.
Measured: 0-6 months
Morbidity
Number and severity of complications will be assed based on medical records.
Measured: 0-6 months
(I)ADL dependence by GARS
Dependence regarding (instrumental) acitivities of daily living ((I)ADL)according to the Gait Assessment Rating Scale (GARS). Several items with regard to self-reliance are scored according to the phrase 'I can do ....(item) completely independently.......'. Possible answers are 'Without any effort', 'with some effort', 'With a lot of effort', and 'Only with help from others'. The first is considered better and the latter as worse.
Measured: 0-6 months
(I)ADL dependence by TOPICS-SF
Dependence regarding (instrumental) acitivities of daily living according toThe Older Persons and Informal Caregivers Survey Short form (TOPICS-SF) questionnaire for patients. This questionnaire contains GARS and EQ-5D amongst others and is spread throughout the questionnaire.
Measured: 0-6 months
Return to normal activity
The return to normal activity (RNA) of patients is investigated by the different questionnaires listed above on several time-points. After surgery, we can examine the time within a time frame of 6 months that patients return to their normal activities.
Measured: 0-6 months
Care-related burden among informal caregivers
The Older Persons and Informal Caregivers Survey Minimum Dataset (TOPICS-MDS) questionnaire for caregivers in which the domains 'self-reported health' (by RAND-36 health survey), 'quality of life' (by carerQol), 'hours of informal care' (number), and 'perceived burden' (on visual analog scale) are covered.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Inclusions lagged far behind
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Leading the Change: Collaboration of health Insurers in the Netherlands
- Responsible party
- Sponsor
- Investigators
- Marcel G Olde Rikkert, MD PhD, Principal investigator, Department of Geriatric Medicine, RadboudUmC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097795
- Sponsor's protocol ID
- PreColo CU
- Acronym
- PreColo CU
- Status last verified
- Mar 2021
- First submitted
- 12 Sep 2019
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incremental Cost-utility Study on Prehabilitation for Colon Cancer Surgery in Older Patients
- ClinicalTrials.gov ID
- NCT04097795
- Acronym / sponsor ID
- PreColo CU / PreColo CU
- Conditions
- Colorectal Cancer, Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inclusions lagged far behind
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Leading the Change: Collaboration of health Insurers in the Netherlands
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Sep 2019 (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.
A prospective multicenter observational cost-utility study following older or high-risk patients with colorectal cancer with and without prehabilitation before surgery.
Detailed description
This study will answer the question whether prehabilitation is cost-effective in colorectal cancer surgery among individual patients aged 70 years and above or patients with an American Society of Anesthesiologists (ASA) score of III. We also aim to identify factors facilitating or impairing implementation of prehabilitation such that it is cost-effective.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | – | Other: PrehabilitationPatients aged 70 years and above or with an American Society of Anesthesiologists (ASA) score of III, who are scheduled for colorectal cancer surgery in one of the participating hospitals which offer prehabilitation. |
| No prehabilitation | – | –Patients aged 70 years and above or with an American Society of Anesthesiologists (ASA) score of III, who are scheduled for colorectal cancer surgery in one of the participating hospitals which do not offer prehabilitation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 70 years and above or patients with an ASA III score who are diagnosed with colorectal cancer and are scheduled for surgery as primary intervention will be recruited in the outpatient clinic of the surgery department of the participating hospitals.
Key inclusion criteria (2 listed)
- Age ≥ 70 years or American Society of Anesthesiologists (ASA) score of III
- Scheduled for colorectal cancer surgery
Key exclusion criteria (5 listed)
- Metastatic disease known preoperatively
- ASA IV score or higher
- Paralytic or immobilized patients (not capable to perform exercise)
- Prior use of neoadjuvant therapy for the same indication
- Not able or willing to provide written informed consent
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 |
|---|---|---|
| PrehabilitationAccording to our definition, prehabilitation consists of exercise therapy during at least 2 weeks. This is combined with optimalisation of the patients' nutritional status at least 2 weeks before surgery. | Other | Prehabilitation |
Primary outcome
EQ-5D-5L
Time frame: 0-6 months
Quality of life according to the EuroQol-5 dimensions-5 levels questionnaire. The 5 dimensions cover mobility, selfcare, daily activities, pain/discomfort and anxiety. All dimensions are rated on a 5 level scale ranging from 'I have no problems with ....(dimension)' to 'I am not able to/I am extremely...(dimension)'. The first option is considered 'better' and the latter as 'worse'.
Costs
Time frame: 0-6 months
From a societal perspective including health care consumption costs, patient out-of-pocket costs, and productivity losses of informal caregivers
6 secondary outcomes
Number of deceased patients
Time frame: 0-6 months
Morbidity
Time frame: 0-6 months
(I)ADL dependence by GARS
Time frame: 0-6 months
(I)ADL dependence by TOPICS-SF
Time frame: 0-6 months
Return to normal activity
Time frame: 0-6 months
Care-related burden among informal caregivers
Time frame: 0-6 months
Results and safety
The study was stopped early (reason given: Inclusions lagged far behind). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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 G Olde Rikkert, MD PhD principal investigator
Department of Geriatric Medicine, RadboudUmC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Surgery, run by Radboud University Medical Center at 5 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 5 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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: Inclusions lagged far behind). 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?
EQ-5D-5L (time frame: 0-6 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 18 Dec 2023.