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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02000011
Acronym
epigac
Enrollment
50
Registered
2013-12-03
Start date
2014-05-23
Completion date
2022-10-27
Last updated
2022-11-14

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

Conditions

Cancer

Keywords

patients, aged 70 years old, thoracic,, digestive or, urological, resectable

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.

Interventions

OTHERGeriatric intervention plan (GIP)

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
the 6-month autonomy after surgery24 MONTHS

Secondary

MeasureTime frame
12-month autonomy48 months

Countries

France

Outcome results

None listed

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