Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre

This study has been completed.
Sponsor:
Collaborator:
Hôpital Gériatrique Les Bateliers, CHRU Lille
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01415258
First received: August 10, 2011
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

The objective of this study is to uncover the prevalence of vulnerability among patients aged ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the short screening test Vulnerable Elders Survey 13 (VES-13).

The objective is to better understand the value of routine screening of patients before the consultation, it was proposed as a secondary objective of this study to assess the correlation between the identification of the vulnerability in the screening test VES-13 and the identification made ​​by the clinician during the consultation. The correlation between VES-13 and opinion of the clinician for three categories of patients (self - intermediate - fragile) will also be studied.


Condition
Solid Tumor

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • To assess the Vulnerable Elders Survey score (VES-13) [ Time Frame: Within 3 months after recruitment ] [ Designated as safety issue: No ]
    A patient is identified vulnerable if the score is ≥ 3


Secondary Outcome Measures:
  • To assess the correlation between the VES-13 score and the vulnerability judged by a clinical expert [ Time Frame: Within 3 months after recruitment ] [ Designated as safety issue: No ]
    A patient will be identified as vulnerable if he/she belongs to the "intermediate" or "frail" category. The Kappa coefficient of agreement will be used to correlate the VES-13 score and clinical observations.

  • To measure the muscle strength using the grip strength test [ Time Frame: Within 3 months after recruitment ] [ Designated as safety issue: No ]
    Hand Dynamometer Range values : 0-90


Enrollment: 209
Study Start Date: March 2011
Study Completion Date: April 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study concerns elderly patients (≥70 years) with solid tumors

Criteria

Inclusion Criteria:

  • patient aged ≥ 70
  • coming for a first visit, whatever the purpose and the disease stage

Exclusion Criteria:

  • neglect or refusal to answer to the VES-13 test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415258

Locations
France
Oscar Lambret Anti-Cancer Centre
Lille cedex, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Hôpital Gériatrique Les Bateliers, CHRU Lille
Investigators
Principal Investigator: Véronique SERVENT, MD Oscar Lambret Anti-Cancer Centre
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01415258     History of Changes
Other Study ID Numbers: VULNERABILITE-1103
Study First Received: August 10, 2011
Last Updated: May 15, 2012
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Conseil National de l'Ordre des Médecins

Keywords provided by Centre Oscar Lambret:
cancer
vulnerability
frail

ClinicalTrials.gov processed this record on April 17, 2014