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

Cancer Clinical Trial

— epigac  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000011
• Other study ID #: 2013-A01038-37
• Secondary ID: 2013-33
• Status: Completed
• Phase: N/A
• Start date: May 23, 2014
• Est. completion date: October 27, 2022

Study information

• Verified date: November 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 27, 2022
• Est. primary completion date: April 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• comprehensive geriatric assessment (CGA)

• Geriatric intervention plan (GIP)

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the 6-month autonomy after surgery		24 MONTHS
Secondary	12-month autonomy		48 months