Complex Peri-operative Intervention in Older Patients With Cancer

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04709055

Acronym

IMPROVED

Enrollment

630

Registered

2021-01-14

Start date

2021-01-14

Completion date

2024-10-14

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive Cancer

Keywords

Age, Geriatric Assesment, Co-management, Surgery, Digestive Cancer

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

Interventions

OTHERCo-management

Personalized and intensive geriatric peri-operative care

OTHERUsual care

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Mini-Geriatric Depressive Scale	at Day 14 and Day 30 after surgery
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
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
Instrumental Activities of Daily Living Scale	at Day 14 and Day 30 after surgery
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
Percentage of patients with postponed surgeries	at Day 0 to Day 8

Countries

France

Contacts

Primary ContactElena PAILLAUD LAURENT PUIG, MD, PhD

elena.paillaud@aphp.fr(0)1 56 09 21 64

Backup ContactFrédérique PESCHAUD, MD, PhD

frederique.peschaud@aphp.fr(0)1 49 09 53 35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026