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

January 15, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
630

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75015
        • Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo
Time Frame: at 30 days after surgery
at 30 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of patients with postoperative complications of each grade in the Clavien-Dindo
Time Frame: at Day 14 and Day 30
at Day 14 and Day 30
Percentage of patients with each complication among a prespecified list of complication
Time Frame: at Day 14 and Day 30
at Day 14 and Day 30
Social Status
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Activities of Daily Living Scale
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Instrumental Activities of Daily Living Scale
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Mini-Geriatric Depressive Scale
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Mini cognitive scale
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Updated Charlson Comorbidity Index
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Mini Nutritional Assessment-Short Form
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Body mass index
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Timed Up and Go
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Gait speed
Time Frame: at Day 14 and Day 30 after surgery
at Day 14 and Day 30 after surgery
Percentage of patients with cancelled surgeries
Time Frame: at Day 0 to Day 8
at Day 0 to Day 8
Percentage of patients with postponed surgeries
Time Frame: at Day 0 to Day 8
at Day 0 to Day 8
Percentage of patients with complete intervention in the experimental arm
Time Frame: at Day 0 to Day 8
at Day 0 to Day 8
Time of onset of each post-operative complication
Time Frame: at Day 14, Day 30 and Day 90 after surgery
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.
Time Frame: at Day 14, Day 30 and Day 90 after surgery
at Day 14, Day 30 and Day 90 after surgery
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
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)
Time Frame: at Day 30 and Day 90 after surgery
at Day 30 and Day 90 after surgery
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
at Day 30 and Day 90 after surgery
Overall survival
Time Frame: at Day 30 and Day 90 after surgery
at Day 30 and Day 90 after surgery
Length of hospitalizations
Time Frame: at Day 14 after surgery
at Day 14 after surgery
Percentage of patients returned at home or institutionalization
Time Frame: at Day 14, Day 30 and Day 90 after surgery
at Day 14, Day 30 and Day 90 after surgery
Autonomy (Activities of Daily Living scale)
Time Frame: at Day 14 , Day 30 and Day 90 after surgery
at Day 14 , Day 30 and Day 90 after surgery
Patient and professionals experience (ancillary study using semi-directive interviews)
Time Frame: at Day 30 after surgery
at Day 30 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federation of Research in Surgery (FRENCH)
Société Francophone d'Onco-Gériatrie
PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elena PAILLAUD LAURENT PUIG, MD, PhD, Assistance Publique Hôpitaux de Paris (AP-HP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 14, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings