Complex Peri-operative Intervention in Older Patients With Cancer

Digestive Cancer Clinical Trial

— IMPROVED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04709055
• Other study ID #: APHP180675
• Secondary ID: 2020-A01354-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: October 14, 2024

Study information

• Verified date: September 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Elena PAILLAUD LAURENT PUIG, MD, PhD
• Phone: (0)1 56 09 21 64
• Email: elena.paillaud[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 630
• Est. completion date: October 14, 2024
• Est. primary completion date: August 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• Co-management
Personalized and intensive geriatric peri-operative care
• Usual care
Pre-operative and post-operative geriatric care as per usual practice

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Federation of Research in Surgery (FRENCH), PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer, Société Francophone d'Onco-Gériatrie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo		at 30 days after surgery
Secondary	Percentage of patients with postoperative complications of each grade in the Clavien-Dindo		at Day 14 and Day 30
Secondary	Percentage of patients with each complication among a prespecified list of complication		at Day 14 and Day 30
Secondary	Social Status		at Day 14 and Day 30 after surgery
Secondary	Activities of Daily Living Scale		at Day 14 and Day 30 after surgery
Secondary	Instrumental Activities of Daily Living Scale		at Day 14 and Day 30 after surgery
Secondary	Mini-Geriatric Depressive Scale		at Day 14 and Day 30 after surgery
Secondary	Mini cognitive scale		at Day 14 and Day 30 after surgery
Secondary	Updated Charlson Comorbidity Index		at Day 14 and Day 30 after surgery
Secondary	Mini Nutritional Assessment-Short Form		at Day 14 and Day 30 after surgery
Secondary	Body mass index		at Day 14 and Day 30 after surgery
Secondary	Timed Up and Go		at Day 14 and Day 30 after surgery
Secondary	Gait speed		at Day 14 and Day 30 after surgery
Secondary	Percentage of patients with cancelled surgeries		at Day 0 to Day 8
Secondary	Percentage of patients with postponed surgeries		at Day 0 to Day 8
Secondary	Percentage of patients with complete intervention in the experimental arm		at Day 0 to Day 8
Secondary	Time of onset of each post-operative complication		at Day 14, Day 30 and Day 90 after surgery
Secondary	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
Secondary	Length of stay to geriatric unit, intensive care unit, rehabilitation unit or other departement.		at Day 14, Day 30 and Day 90 after surgery
Secondary	Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - C30)		at Day 30 and Day 90 after surgery
Secondary	Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - ELD14)		at Day 30 and Day 90 after surgery
Secondary	Overall survival		at Day 30 and Day 90 after surgery
Secondary	Length of hospitalizations		at Day 14 after surgery
Secondary	Percentage of patients returned at home or institutionalization		at Day 14, Day 30 and Day 90 after surgery
Secondary	Autonomy (Activities of Daily Living scale)		at Day 14 , Day 30 and Day 90 after surgery
Secondary	Patient and professionals experience (ancillary study using semi-directive interviews)		at Day 30 after surgery