Clinical trial NCT02000011: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: patients
aged 70 years old
thoracic,
digestive or
urological
resectable
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: the 6-month autonomy after surgery
timeFrame: 24 MONTHS
Secondary outcomes:
measure: 12-month autonomy
timeFrame: 48 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: LOIC MONDOLONI
role: STUDY_DIRECTOR
References: