Digestive CancerIMPROVEDNCT04709055
Complex Peri-operative Intervention in Older Patients With Cancer
A study testing Co-management in people with Digestive Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Digestive Cancer
- What is being tested?
- Co-management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2021to 14 Oct 2024
- Phase
- Interventional
- 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
Who may be able to join
- Aged 75 years or more
- Gastric, colo-rectal, pancreatic cancer or hepatic metastasis needed a surgical treatment
- Health Insurance
- At risk of post-operative complication through Surgical Risk Calculator (>25%) or surgeon judgment.
- Written consent
Who cannot join
- Surgery in emergency
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou
Paris, 75015
Elena PAILLAUD LAURENT PUIG, MD, PhD, (0)1 56 09 21 64 ext. +33, elena.paillaud@aphp.fr
Frédérique PESCHAUD, MD, PhD, (0)1 49 09 53 35 ext. +33, frederique.peschaud@aphp.fr
About this study
Official title: Implementation of coMplex PeRi-OperatiVe intervEntion in olDer Patients With Cancer : a Multicenter Randomized Controlled Trial
Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Pre-operative Geriatric Assessment enable to identify frail or vulnerable patients at risk of post-operative complications.
The coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.
Read the detailed description
Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint
- Conditions
- Digestive Cancer
- Being tested
- Co-management, Usual care
- Keywords
- Age, Geriatric Assesment, Co-management, Surgery, Digestive Cancer
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-managementOther
Personalized and intensive geriatric peri-operative care
Usual careOther
Pre-operative and post-operative geriatric care as per usual practice
| Study group | Role | What they receive |
|---|---|---|
| Co-management arm (geriatric and surgical) | Experimental | Not described Receives: Other: Co-management |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo
Measured: at 30 days after surgery
Secondary outcomes (25)
Percentage of patients with postoperative complications of each grade in the Clavien-Dindo
Measured: at Day 14 and Day 30
Percentage of patients with each complication among a prespecified list of complication
Measured: at Day 14 and Day 30
Social Status
Measured: at Day 14 and Day 30 after surgery
Activities of Daily Living Scale
Measured: at Day 14 and Day 30 after surgery
Instrumental Activities of Daily Living Scale
Measured: at Day 14 and Day 30 after surgery
Mini-Geriatric Depressive Scale
Measured: at Day 14 and Day 30 after surgery
Mini cognitive scale
Measured: at Day 14 and Day 30 after surgery
Updated Charlson Comorbidity Index
Measured: at Day 14 and Day 30 after surgery
Mini Nutritional Assessment-Short Form
Measured: at Day 14 and Day 30 after surgery
Body mass index
Measured: at Day 14 and Day 30 after surgery
Timed Up and Go
Measured: at Day 14 and Day 30 after surgery
Gait speed
Measured: at Day 14 and Day 30 after surgery
Percentage of patients with cancelled surgeries
Measured: at Day 0 to Day 8
Percentage of patients with postponed surgeries
Measured: at Day 0 to Day 8
Percentage of patients with complete intervention in the experimental arm
Measured: at Day 0 to Day 8
Time of onset of each post-operative complication
Measured: at Day 14, Day 30 and Day 90 after surgery
Percentage of patients transfered to geriatric unit, intensive care unit, rehabilitation unit or other departement.
Measured: at Day 14, Day 30 and Day 90 after surgery
Length of stay to geriatric unit, intensive care unit, rehabilitation unit or other departement.
Measured: at Day 14, Day 30 and Day 90 after surgery
Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - C30)
Measured: at Day 30 and Day 90 after surgery
Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - ELD14)
Measured: at Day 30 and Day 90 after surgery
Overall survival
Measured: at Day 30 and Day 90 after surgery
Length of hospitalizations
Measured: at Day 14 after surgery
Percentage of patients returned at home or institutionalization
Measured: at Day 14, Day 30 and Day 90 after surgery
Autonomy (Activities of Daily Living scale)
Measured: at Day 14 , Day 30 and Day 90 after surgery
Patient and professionals experience (ancillary study using semi-directive interviews)
Measured: at Day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start14 Jan 2021 (estimated)
- Primary completion14 Aug 2024 (estimated)
- Study completion14 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Société Francophone d'Onco-Gériatrie, Federation of Research in Surgery (FRENCH), PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer
- Responsible party
- Sponsor
- Investigators
- Elena PAILLAUD LAURENT PUIG, MD, PhD, Principal investigator, Assistance Publique Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709055
- Sponsor's protocol ID
- APHP180675
- Other IDs
- 2020-A01354-35
- Acronym
- IMPROVED
- Status last verified
- Sep 2020
- First submitted
- 28 Oct 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of coMplex PeRi-OperatiVe intervEntion in olDer Patients With Cancer : a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04709055
- Acronym / sponsor ID
- IMPROVED / APHP180675
- Conditions
- Digestive Cancer
- Keywords
- Age, Geriatric Assesment, Co-management, Surgery, Digestive Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Société Francophone d'Onco-Gériatrie, Federation of Research in Surgery (FRENCH), PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer
- Study start
- 14 Jan 2021 (estimated)
- Primary completion
- 14 Aug 2024 (estimated)
- Study completion
- 14 Oct 2024 (estimated)
- First posted
- 14 Jan 2021 (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.
Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Pre-operative Geriatric Assessment enable to identify frail or vulnerable patients at risk of post-operative complications.
The coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.
Detailed description
Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-management arm (geriatric and surgical) | Experimental | Other: Co-management |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged 75 years or more
- Gastric, colo-rectal, pancreatic cancer or hepatic metastasis needed a surgical treatment
- Health Insurance
- At risk of post-operative complication through Surgical Risk Calculator (>25%) or surgeon judgment.
- Written consent
Key exclusion criteria (1 listed)
- Surgery in emergency
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 |
|---|---|---|
| Co-managementPersonalized and intensive geriatric peri-operative care | Other | Co-management arm (geriatric and surgical) |
| Usual carePre-operative and post-operative geriatric care as per usual practice | Other | Usual care |
Primary outcome
Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo
Time frame: at 30 days after surgery
25 secondary outcomes
Percentage of patients with postoperative complications of each grade in the Clavien-Dindo
Time frame: at Day 14 and Day 30
Percentage of patients with each complication among a prespecified list of complication
Time frame: at Day 14 and Day 30
Social Status
Time frame: at Day 14 and Day 30 after surgery
Activities of Daily Living Scale
Time frame: at Day 14 and Day 30 after surgery
Instrumental Activities of Daily Living Scale
Time frame: at Day 14 and Day 30 after surgery
Mini-Geriatric Depressive Scale
Time frame: at Day 14 and Day 30 after surgery
Mini cognitive scale
Time frame: at Day 14 and Day 30 after surgery
Updated Charlson Comorbidity Index
Time frame: at Day 14 and Day 30 after surgery
Mini Nutritional Assessment-Short Form
Time frame: at Day 14 and Day 30 after surgery
Body mass index
Time frame: at Day 14 and Day 30 after surgery
Timed Up and Go
Time frame: at Day 14 and Day 30 after surgery
Gait speed
Time frame: at Day 14 and Day 30 after surgery
Percentage of patients with cancelled surgeries
Time frame: at Day 0 to Day 8
Percentage of patients with postponed surgeries
Time frame: at Day 0 to Day 8
Percentage of patients with complete intervention in the experimental arm
Time frame: at Day 0 to Day 8
Time of onset of each post-operative complication
Time frame: at Day 14, Day 30 and Day 90 after surgery
Percentage of patients transfered to geriatric unit, intensive care unit, rehabilitation unit or other departement.
Time frame: at Day 14, Day 30 and Day 90 after surgery
Length of stay to geriatric unit, intensive care unit, rehabilitation unit or other departement.
Time frame: at Day 14, Day 30 and Day 90 after surgery
Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - C30)
Time frame: at Day 30 and Day 90 after surgery
Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - ELD14)
Time frame: at Day 30 and Day 90 after surgery
Overall survival
Time frame: at Day 30 and Day 90 after surgery
Length of hospitalizations
Time frame: at Day 14 after surgery
Percentage of patients returned at home or institutionalization
Time frame: at Day 14, Day 30 and Day 90 after surgery
Autonomy (Activities of Daily Living scale)
Time frame: at Day 14 , Day 30 and Day 90 after surgery
Patient and professionals experience (ancillary study using semi-directive interviews)
Time frame: at Day 30 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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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.
Elena PAILLAUD LAURENT PUIG, MD, PhD principal investigator
Assistance Publique Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-management in people with Digestive Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jan 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena PAILLAUD LAURENT PUIG, MD, PhD ((0)1 56 09 21 64 ext. +33, elena.paillaud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo (time frame: at 30 days after surgery). 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 19 Jan 2021.