CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,674 enrolled
Drug / intervention
Geriatric screening tests +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00963911
NCT00963911N/ACompleted

Validation of a Screening Tool in Geriatric Oncology

Institut Bergonié·interventional·Posted Aug 24, 2009·Updated Apr 5, 2021

In Brief

A clinical study evaluating Geriatric screening tests and Multidimensional geriatric assessment for Breast Cancer and 5 related conditions. Completed, enrolled 1,674 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2009
Enrollment StartAug 5, 2008
Primary CompletionMar 8, 2010
Study CompletionMar 8, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.9 years ago

Interventions

Geriatric screening testsother

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.

Multidimensional geriatric assessmentother

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).