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

NCT02000011 | Completed

• 2 other identifiers: 2013-A01038-372013-33
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• the 6-month autonomy after surgery

  24 MONTHS

Secondary Outcomes (1)

• 12-month autonomy

  48 months

Study Arms (2)

standard strategy

OTHER

Other: comprehensive geriatric assessment (CGA)

experimental strategy

EXPERIMENTAL

Other: comprehensive geriatric assessment (CGA); Other: Geriatric intervention plan (GIP)

Interventions

comprehensive geriatric assessment (CGA) OTHER

experimental strategy; standard strategy

Geriatric intervention plan (GIP) OTHER

experimental strategy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Geriatric Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• LOIC MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: May 23, 2014
• Primary Completion: April 18, 2016
• Study Completion: October 27, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

FR (1)