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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014