Complex Peri-operative Intervention in Older Patients With Cancer

Study Overview
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Brief Summary
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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
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Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint

Official Title
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Implementation of coMplex PeRi-OperatiVe intervEntion in olDer Patients With Cancer : a Multicenter Randomized Controlled Trial

Conditions
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Digestive Cancer

Intervention / Treatment
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* Other: Co-management
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Surgery in emergency

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Co-management arm (geriatric and surgical)<br> | Other: Co-management<br>* Personalized and intensive geriatric peri-operative care<br>|
| Active Comparator: Usual care<br> | Other: Usual care<br>* Pre-operative and post-operative geriatric care as per usual practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo |  | at 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with postoperative complications of each grade in the Clavien-Dindo |  | at Day 14 and Day 30 | 
| Percentage of patients with each complication among a prespecified list of complication |  | at Day 14 and Day 30 | 
| Social Status |  | at Day 14 and Day 30 after surgery | 
| Activities of Daily Living Scale |  | at Day 14 and Day 30 after surgery | 
| Instrumental Activities of Daily Living Scale |  | at Day 14 and Day 30 after surgery | 
| Mini-Geriatric Depressive Scale |  | at Day 14 and Day 30 after surgery | 
| Mini cognitive scale |  | at Day 14 and Day 30 after surgery | 
| Updated Charlson Comorbidity Index |  | at Day 14 and Day 30 after surgery | 
| Mini Nutritional Assessment-Short Form |  | at Day 14 and Day 30 after surgery | 
| Body mass index |  | at Day 14 and Day 30 after surgery | 
| Timed Up and Go |  | at Day 14 and Day 30 after surgery | 
| Gait speed |  | at Day 14 and Day 30 after surgery | 
| Percentage of patients with cancelled surgeries |  | at Day 0 to Day 8 | 
| Percentage of patients with postponed surgeries |  | at Day 0 to Day 8 | 
| Percentage of patients with complete intervention in the experimental arm |  | at Day 0 to Day 8 | 
| Time of onset of each post-operative complication |  | 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. |  | at Day 14, Day 30 and Day 90 after surgery | 
| Length of stay to geriatric unit, intensive care unit, rehabilitation unit or other departement. |  | 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) |  | at Day 30 and Day 90 after surgery | 
| Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - ELD14) |  | at Day 30 and Day 90 after surgery | 
| Overall survival |  | at Day 30 and Day 90 after surgery | 
| Length of hospitalizations |  | at Day 14 after surgery | 
| Percentage of patients returned at home or institutionalization |  | at Day 14, Day 30 and Day 90 after surgery | 
| Autonomy (Activities of Daily Living scale) |  | at Day 14 , Day 30 and Day 90 after surgery | 
| Patient and professionals experience (ancillary study using semi-directive interviews) |  | at Day 30 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age, Geriatric Assesment, Co-management, Surgery, Digestive Cancer