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Clinical Trials/NCT00963911
NCT00963911
Completed
Not Applicable

Validation of a Screening Tool in Geriatric Oncology

Institut Bergonié1 site in 1 country1,674 target enrollmentAugust 5, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Institut Bergonié
Enrollment
1674
Locations
1
Primary Endpoint
Sensitivity of the G8 Questionnaire
Status
Completed
Last Updated
5 years ago

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). OUTLINE: This is a multicenter study. During the first consultation, patients have an initial clinical evaluation questionnaire comprising the G8. They also complete the self-questionnaire VES-13. Within 30 days, patients have a thorough geriatric assessment, including quality of life and physical function, by a physician without access to the G8 or VES-13 questionnaires. A blood specimen is also collected. Information on health status and quality of life is collected from medical records or from the doctor after 1 and 5 years.

Registry
clinicaltrials.gov
Start Date
August 5, 2008
End Date
March 8, 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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))

Study Sites (1)

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