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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

comprehensive geriatric assessment (CGA)

Other

Geriatric intervention plan (GIP)

Other

Primary outcomes

  1. the 6-month autonomy after surgery

    Time frame: 24 MONTHS

Secondary outcomes

  1. 12-month autonomy

    Time frame: 48 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: epigac

Important dates

Study start
2014
Primary completion
2016
Study completion
2022
First posted
Dec 3, 2013
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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