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

Primary Purpose

Digestive Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Co-management
Usual care
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Digestive Cancer focused on measuring Age, Geriatric Assesment, Co-management, Surgery, Digestive Cancer

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

  • Surgery in emergency

Sites / Locations

  • Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Co-management arm (geriatric and surgical)

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo

Secondary Outcome Measures

Percentage of patients with postoperative complications of each grade in the Clavien-Dindo
Percentage of patients with each complication among a prespecified list of complication
Social Status
Activities of Daily Living Scale
Instrumental Activities of Daily Living Scale
Mini-Geriatric Depressive Scale
Mini cognitive scale
Updated Charlson Comorbidity Index
Mini Nutritional Assessment-Short Form
Body mass index
Timed Up and Go
Gait speed
Percentage of patients with cancelled surgeries
Percentage of patients with postponed surgeries
Percentage of patients with complete intervention in the experimental arm
Time of onset of each post-operative complication
Percentage of patients transfered to geriatric unit, intensive care unit, rehabilitation unit or other departement.
Length of stay to geriatric unit, intensive care unit, rehabilitation unit or other departement.
Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - C30)
Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - ELD14)
Overall survival
Length of hospitalizations
Percentage of patients returned at home or institutionalization
Autonomy (Activities of Daily Living scale)
Patient and professionals experience (ancillary study using semi-directive interviews)

Full Information

First Posted
October 28, 2020
Last Updated
January 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Société Francophone d'Onco-Gériatrie, Federation of Research in Surgery (FRENCH), PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer
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1. Study Identification

Unique Protocol Identification Number
NCT04709055
Brief Title
Complex Peri-operative Intervention in Older Patients With Cancer
Acronym
IMPROVED
Official Title
Implementation of coMplex PeRi-OperatiVe intervEntion in olDer Patients With Cancer : a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 14, 2021 (Anticipated)
Primary Completion Date
August 14, 2024 (Anticipated)
Study Completion Date
October 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Société Francophone d'Onco-Gériatrie, Federation of Research in Surgery (FRENCH), PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive Cancer
Keywords
Age, Geriatric Assesment, Co-management, Surgery, Digestive Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
630 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Co-management arm (geriatric and surgical)
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Co-management
Intervention Description
Personalized and intensive geriatric peri-operative care
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Pre-operative and post-operative geriatric care as per usual practice
Primary Outcome Measure Information:
Title
Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo
Time Frame
at 30 days after surgery
Secondary Outcome Measure Information:
Title
Percentage of patients with postoperative complications of each grade in the Clavien-Dindo
Time Frame
at Day 14 and Day 30
Title
Percentage of patients with each complication among a prespecified list of complication
Time Frame
at Day 14 and Day 30
Title
Social Status
Time Frame
at Day 14 and Day 30 after surgery
Title
Activities of Daily Living Scale
Time Frame
at Day 14 and Day 30 after surgery
Title
Instrumental Activities of Daily Living Scale
Time Frame
at Day 14 and Day 30 after surgery
Title
Mini-Geriatric Depressive Scale
Time Frame
at Day 14 and Day 30 after surgery
Title
Mini cognitive scale
Time Frame
at Day 14 and Day 30 after surgery
Title
Updated Charlson Comorbidity Index
Time Frame
at Day 14 and Day 30 after surgery
Title
Mini Nutritional Assessment-Short Form
Time Frame
at Day 14 and Day 30 after surgery
Title
Body mass index
Time Frame
at Day 14 and Day 30 after surgery
Title
Timed Up and Go
Time Frame
at Day 14 and Day 30 after surgery
Title
Gait speed
Time Frame
at Day 14 and Day 30 after surgery
Title
Percentage of patients with cancelled surgeries
Time Frame
at Day 0 to Day 8
Title
Percentage of patients with postponed surgeries
Time Frame
at Day 0 to Day 8
Title
Percentage of patients with complete intervention in the experimental arm
Time Frame
at Day 0 to Day 8
Title
Time of onset of each post-operative complication
Time Frame
at Day 14, Day 30 and Day 90 after surgery
Title
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
Title
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
Title
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
Title
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
Title
Overall survival
Time Frame
at Day 30 and Day 90 after surgery
Title
Length of hospitalizations
Time Frame
at Day 14 after surgery
Title
Percentage of patients returned at home or institutionalization
Time Frame
at Day 14, Day 30 and Day 90 after surgery
Title
Autonomy (Activities of Daily Living scale)
Time Frame
at Day 14 , Day 30 and Day 90 after surgery
Title
Patient and professionals experience (ancillary study using semi-directive interviews)
Time Frame
at Day 30 after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena PAILLAUD LAURENT PUIG, MD, PhD
Phone
(0)1 56 09 21 64
Ext
+33
Email
elena.paillaud@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Frédérique PESCHAUD, MD, PhD
Phone
(0)1 49 09 53 35
Ext
+33
Email
frederique.peschaud@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena PAILLAUD LAURENT PUIG, MD, PhD
Organizational Affiliation
Assistance Publique Hôpitaux de Paris (AP-HP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena PAILLAUD LAURENT PUIG, MD, PhD
Phone
(0)1 56 09 21 64
Ext
+33
Email
elena.paillaud@aphp.fr
First Name & Middle Initial & Last Name & Degree
Frédérique PESCHAUD, MD, PhD
Phone
(0)1 49 09 53 35
Ext
+33
Email
frederique.peschaud@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Complex Peri-operative Intervention in Older Patients With Cancer

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