Clinical trial NCT04709055: Complex Peri-operative Intervention in Older Patients With Cancer
Official title: Implementation of coMplex PeRi-OperatiVe intervEntion in olDer Patients With Cancer : a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Digestive Cancer
Keywords: Age
Geriatric Assesment
Co-management
Surgery
Digestive Cancer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Société Francophone d'Onco-Gériatrie
name: Federation of Research in Surgery (FRENCH)
name: PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer
First posted: 2021-01-14
Enrollment: 630
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo
timeFrame: at 30 days after surgery
Secondary outcomes:
measure: Percentage of patients with postoperative complications of each grade in the Clavien-Dindo
timeFrame: at Day 14 and Day 30
measure: Percentage of patients with each complication among a prespecified list of complication
timeFrame: at Day 14 and Day 30
measure: Social Status
timeFrame: at Day 14 and Day 30 after surgery
measure: Activities of Daily Living Scale
timeFrame: at Day 14 and Day 30 after surgery
measure: Instrumental Activities of Daily Living Scale
timeFrame: at Day 14 and Day 30 after surgery
measure: Mini-Geriatric Depressive Scale
timeFrame: at Day 14 and Day 30 after surgery
measure: Mini cognitive scale
timeFrame: at Day 14 and Day 30 after surgery
measure: Updated Charlson Comorbidity Index
timeFrame: at Day 14 and Day 30 after surgery
measure: Mini Nutritional Assessment-Short Form
timeFrame: at Day 14 and Day 30 after surgery
measure: Body mass index
timeFrame: at Day 14 and Day 30 after surgery
measure: Timed Up and Go
timeFrame: at Day 14 and Day 30 after surgery
measure: Gait speed
timeFrame: at Day 14 and Day 30 after surgery
measure: Percentage of patients with cancelled surgeries
timeFrame: at Day 0 to Day 8
measure: Percentage of patients with postponed surgeries
timeFrame: at Day 0 to Day 8
measure: Percentage of patients with complete intervention in the experimental arm
timeFrame: at Day 0 to Day 8
measure: Time of onset of each post-operative complication
timeFrame: at Day 14, Day 30 and Day 90 after surgery
measure: Percentage of patients transfered to geriatric unit, intensive care unit, rehabilitation unit or other departement.
timeFrame: at Day 14, Day 30 and Day 90 after surgery
measure: Length of stay to geriatric unit, intensive care unit, rehabilitation unit or other departement.
timeFrame: at Day 14, Day 30 and Day 90 after surgery
measure: Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - C30)
timeFrame: at Day 30 and Day 90 after surgery
measure: Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - ELD14)
timeFrame: at Day 30 and Day 90 after surgery
measure: Overall survival
timeFrame: at Day 30 and Day 90 after surgery
measure: Length of hospitalizations
timeFrame: at Day 14 after surgery
measure: Percentage of patients returned at home or institutionalization
timeFrame: at Day 14, Day 30 and Day 90 after surgery
measure: Autonomy (Activities of Daily Living scale)
timeFrame: at Day 14 , Day 30 and Day 90 after surgery
measure: Patient and professionals experience (ancillary study using semi-directive interviews)
timeFrame: at Day 30 after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris (AP-HP)
name: Elena PAILLAUD LAURENT PUIG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: