Validation of a Screening Tool in Geriatric Oncology
NCT00963911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1674
Last updated 2021-04-05
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.
Conditions
Interventions
- OTHER
-
Geriatric screening tests
The G-8 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 and the time taken to complete the test was recorded. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For three pre-identified centers, patients also filled in the questionnaire at the following geriatric visit. VES-13 consisted of four groups of questions: age, self-perceived health, difficulties to perform six specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score \>=3 was considered to show impairment.
- OTHER
-
Multidimensional geriatric assessment
Patients underwent a geriatric evaluation in the month following the completion of G8 and VES-13 (+/- seven days) before treatment began. The nurse completed six of the seven instruments of the MGA (MNA, Timed Get up and Go (TUG), Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini Mental State Examination (MMSE), and Geriatric Depression Scale (GDS-15)), and the geriatrician rated comorbidity on the Cumulative Illness Rating Scale (CIRS-G), recorded the time required for the consultation, identified patients who needed personalized geriatric interventions, and, if necessary, proposed further geriatric evaluation (outside of the scope of this study).
Sponsors & Collaborators
-
National Cancer Institute, France
collaborator OTHER_GOV -
Institut Bergonié
lead OTHER
Principal Investigators
-
Pierre Soubeyran, MD, PhD · Institut Bergonié
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-08-05
- Primary Completion
- 2010-03-08
- Completion
- 2015-03-08
Countries
- France
Study Locations
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