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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415258
• Other study ID #: VULNERABILITE-1103
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: May 15, 2012
• Start date: March 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Conseil National de l'Ordre des Médecins
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: April 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Solid Tumor

Locations

Country	Name	City	State
France	Oscar Lambret Anti-Cancer Centre	Lille cedex

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Hôpital Gériatrique Les Bateliers, CHRU Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the Vulnerable Elders Survey score (VES-13)	A patient is identified vulnerable if the score is = 3	Within 3 months after recruitment	No
Secondary	To assess the correlation between the VES-13 score and the vulnerability judged by a clinical expert	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.	Within 3 months after recruitment	No
Secondary	To measure the muscle strength using the grip strength test	Hand Dynamometer Range values : 0-90	Within 3 months after recruitment	No