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 (epigac)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: comprehensive geriatric assessment (CGA); Other: Geriatric intervention plan (GIP)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: standard strategy	Other: comprehensive geriatric assessment (CGA)
Experimental: experimental strategy	Other: comprehensive geriatric assessment (CGA); Other: Geriatric intervention plan (GIP)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
12-month autonomy	48 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2014
• Primary Completion (Actual): April 18, 2016
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: patients; resectable; aged 70 years old; thoracic,; digestive or; urological
• Other Study ID Numbers: 2013-A01038-37; 2013-33 (Other Identifier: AP HM)