Validation of a Screening Tool in Geriatric Oncology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Bergonié
- 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))