Interest of a Geriatric Intervention Plan Associated to a Comprehensive Geriatric Assessment on Autonomy, Quality of Life and Survival of Patients Aged 70 Years Old and More Surgically Treated for a Resectable Cancer (Thoracic, Digestive or Urologic). Randomized Multicentric Study

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: comprehensive geriatric assessment (CGA); Other: Geriatric intervention plan (GIP)

• Registration Number: NCT02000011
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. For patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old patient population without cancer, CGA associated with a geriatric intervention plan (GIP) allows autonomy preservation, decrease of institution admission, and survival improvement. The reference study showed that a CGA associated to a GIP improves survival of old patients who had a cancer surgery. However this study included patients from 60 years old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.

We propose to perform a prospective and randomized study to evaluate the impact of a CGA with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. The impact of such a strategy on autonomy and survival has never been studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-03
• Study Start: 2014-05-23
• Primary Completion: 2016-04-18
• Study Completion: 2022-10-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male or female aged 70 years old or more
• Patient with a resectable cancer( thoracic, digestive ore urologic);
• Patients who have to undergo a surgery with general anaesthesia;
• Patients treated in one of the partner programme unit ;
• Patient able to fill in an auto-questionnaire alone or with some help;
• Patient who have signed an informed consent and who commits himself or herself to respect the protocol instructions.

Exclusion Criteria

• Patient younger than 70 years old;
• Patient who is not registered to the social ;
• Patient for whom surgery is performed under local anaesthesia;
• Patient unable to fill-in alone an autoquestionnaire (because of an inability to read French language or severe cognitive troubles);
• Patient treated with neuroleptic or lithium ;
• Patient with already known cognitive impairment (Alzheimer, dementia, neurologic sequel);
• Patient under legal protection;
• Patient who has not signed informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental strategy	comprehensive geriatric assessment (CGA)	-
standard strategy	comprehensive geriatric assessment (CGA)	-
experimental strategy	Geriatric intervention plan (GIP)	-

Primary Outcome Measures

Name	Time	Method
the 6-month autonomy after surgery	24 MONTHS

Secondary Outcome Measures

Name	Time	Method
12-month autonomy	48 months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France