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

NCT ID: NCT02000011

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-23
• Study Completion Date: 2022-10-27

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

standard strategy

Group Type: OTHER

comprehensive geriatric assessment (CGA)

Intervention Type: OTHER

experimental strategy

Group Type: EXPERIMENTAL

comprehensive geriatric assessment (CGA)

Intervention Type: OTHER

Geriatric intervention plan (GIP)

Intervention Type: OTHER

Interventions

comprehensive geriatric assessment (CGA)

Intervention Type: OTHER

Geriatric intervention plan (GIP)

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LOIC MONDOLONI

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2013-33

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A01038-37

Identifier Type: -

Identifier Source: org_study_id