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Clinical Trials/NCT00963911
NCT00963911CompletedNot Applicable

Validation of a Screening Tool in Geriatric Oncology

Institut Bergonié2 sites in 1 country1,674 target enrollmentStarted: August 5, 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,674
Locations
2
Primary Endpoint
Sensitivity of the G8 Questionnaire

Study Overview

Brief Summary

RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer.

PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.

Detailed Description

OBJECTIVES:

Primary

  • Validate a new screening tool (G8).

Secondary

  • Validate the French version of the screening tool "Vulnerable Elders Survey (VES-13)".
  • Evaluate the merits of the screening tools (G8 and VES-13).
  • Assess the screening tool in specific populations.
  • Assess the number and type of interventions proposed after thorough geriatric assessment.
  • Compare the two new tools (G8 vs VES-13).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
70 Years to 120 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Sensitivity of the G8 Questionnaire

Time Frame: at inclusion (at completion of the G8 questionnaire)

Sensitivity of the G8 questionnaire measured as Percentage of Participants with a Positive G8 among patients with a positive MGA. The G8 consists of eight items: patient age (\>85, 80-85, \<80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was \<=14. Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale.

Secondary Outcomes

  • Specificity of the G8 Questionnaire(at inclusion (at completion of the G8 questionnaire))
  • Sensitivity of the VES-13 Questionnaire(at inclusion)
  • Specificity of the VES-13 Questionnaire(at inclusion (at completion of the G8 questionnaire))
  • Reproducibility of the VES-13 Questionnaire(at inclusion (at completion of the G8 questionnaire))
  • Reproducibility of the G8 Questionnaire(at inclusion (at completion of the G8 questionnaire))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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