IMPROVED: Complex Peri-operative Intervention in Older Patients With Cancer

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04709055

Collaborator

Société Francophone d'Onco-Gériatrie (Other), Federation of Research in Surgery (FRENCH) (Other), PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer (Other)

630

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive Cancer	Other: Co-management Other: Usual care	N/A

Detailed Description

Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint

Study Design

Study Type:

Interventional

Anticipated Enrollment :

630 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 14, 2021

Anticipated Primary Completion Date :

Aug 14, 2024

Anticipated Study Completion Date :

Oct 14, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Co-management arm (geriatric and surgical)

Other: Co-management

Personalized and intensive geriatric peri-operative care

Active Comparator: Usual care

Other: Usual care

Pre-operative and post-operative geriatric care as per usual practice

Outcome Measures

Primary Outcome Measures

Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo [at 30 days after surgery]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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