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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Other: comprehensive geriatric assessment (CGA)
* Other: Geriatric intervention plan (GIP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: standard strategy<br> | Other: comprehensive geriatric assessment (CGA)<br> <br> |
| Experimental: experimental strategy<br> | Other: comprehensive geriatric assessment (CGA)<br> <br> Other: Geriatric intervention plan (GIP)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 6-month autonomy after surgery |  | 24 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month autonomy |  | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients, aged 70 years old, thoracic,, digestive or, urological, resectable