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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

Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: comprehensive geriatric assessment (CGA) (Other); Geriatric intervention plan (GIP) (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Assistance Publique Hopitaux De Marseille

Official(s) and/or principal investigator(s):
LOIC MONDOLONI, Study Director, Affiliation: Assistance Publique Hopitaux De Marseille

Overall contact:
vincent moutardier, Email: vincent.moutardier@ap-hm.fr

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: the 6-month autonomy after surgery

Secondary outcome: 12-month autonomy

Eligibility

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

vincent moutardier, Email: vincent.moutardier@ap-hm.fr

Assistance Publique Hopitaux de Marseille, Marseille 13354, France; Recruiting
vincent moutardier, Email: vincent.moutardier@ap-hm.fr
vincent moutardier, Principal Investigator
Additional Information

Starting date: December 2013
Last updated: August 6, 2015

Page last updated: August 23, 2015

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