Complex Peri-operative Intervention in Older Patients With Cancer (IMPROVED)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Digestive Cancer
• Intervention / Treatment: Other: Co-management; Other: Usual care

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 630
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena PAILLAUD LAURENT PUIG, MD, PhD; Phone Number: +33 (0)1 56 09 21 64; Email: elena.paillaud@aphp.fr
• Study Contact Backup: Name: Frédérique PESCHAUD, MD, PhD; Phone Number: +33 (0)1 49 09 53 35; Email: frederique.peschaud@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou
    • Contact: Elena PAILLAUD LAURENT PUIG, MD, PhD; Phone Number: +33 (0)1 56 09 21 64; Email: elena.paillaud@aphp.fr
    • Contact: Frédérique PESCHAUD, MD, PhD; Phone Number: +33 (0)1 49 09 53 35; Email: frederique.peschaud@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Federation of Research in Surgery (FRENCH); Société Francophone d'Onco-Gériatrie; PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer
• Investigators: Principal Investigator: Elena PAILLAUD LAURENT PUIG, MD, PhD, Assistance Publique Hopitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Anticipated): January 14, 2021
• Primary Completion (Anticipated): August 14, 2024
• Study Completion (Anticipated): October 14, 2024

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Age; Digestive Cancer; Co-management; Geriatric Assesment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: APHP180675; 2020-A01354-35 (Other Identifier: N° IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No