MOST is a longitudinal study whose aim is to test the hypothesis that frailty markers are better at detecting vulnerable patients and that they are a better "Adverse Events" predictive tool than the CGA (Comprehensive Geriatric Assessment) in older cancer patients referred for chemotherapy. The second hypothesis is that a brief screening tool based on a combination of some frailty markers and some used in the CGA would help the oncologist detect patients requiring a more complete geriatric assessment
For older cancer patients, Comprehensive Geriatric Assessment (CGA) is recommended in order to help the oncologist in his decision making. However, the implementation of the CGA in oncologic setting presents major limitations; The CGA is time consuming, costly in terms of resources and is not standardized. Moreover, recent studies show that the CGA, used as the gold standard, may have a ceiling effect in detecting vulnerability in older cancer patients. Several authors suggest that a more sensitive approach, using frailty markers may be a better way to detect potential vulnerability in older cancer patients. In this study, for each patient, a brief screening assessment, a full CGA and the assessment of frailty markers will be completed at inclusion. The brief screening assessment will be based on self report questionnaire (4 items of instrumental Activities of Daily Living + 2 items of nutritional assessment) and one physical measure (one-leg standing balance test). The CGA will be based on seven domains (and their assessment tools): functional status, comorbidities, objective physical performance, nutrition, cognition, depression, and social support. Five frailty markers (as described by Fried and al) will be evaluated: nutrition, mobility, energy, physical activity and grip strength. CGA and frailty markers will be completed at 3, 6, 12 and 18 months after the beginning of chemotherapy as well as oncologic criteria (treatment toxicities, treatment modification such as decrease or change or end of chemotherapy, percentage of chemotherapy dose received, cancer related death) and geriatric criteria for adverse outcomes (functional, nutritional or cognition decline, hospitalization or consultation with their general practitioner, death for other causes).
Study Type
OBSERVATIONAL
Enrollment
180
Brief screening assessment, CGA and frailty markers will be evaluate at inclusion. CGA and frailty markers will be evaluated at 3, 6, 12 and 18 months after the beginning of chemotherapy. Criteria for toxicity and adverse outcomes will be recorded at each cycle or visits
Hôpital d'Aix en Provence
Aix-en-Provence, France
Centre Hospitalier de la Dracénie
Draguignan, France
Hôpital Européen Marseille
Marseille, France
Institut Paoli Calmette
Marseille, France
Occurrence of Adverse Events
The primary endpoint analysis is defined by the relationship between the CGA (Comprehensive Geriatric Assessment) and frailty markers on the one hand and the occurrence of adverse events on the other. The effect of each tool will be evaluated using a Cox model. The results will be adjusted on the main prognostic factors (age, type and stage of cancer).
Time frame: up to 18 months
Performance of the brief screening tool
A second analysis will also evaluate the performance of the brief screening tool by determining its efficiency (specificity, sensitivity, positive and negative predictive values and accuracy) within the sample population in comparison to the CGA's and frailty markers. Estimations will be computed with a 95 % confidence interval.
Time frame: 3, 6, 12 and 18 months
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Pôle de Gérontologie, Service de Gériatrie Aigue et Thérapeutique
Nice, France
Hôpital de Pontoise Centre Hospitalier René Dubos
Pontoise, Val-d'Oise, France
Centre Hospitalier Universitaire Intercommunal des Alpes du Sud
Sisteron, France
Centre Hospitalier Intercommunal
Toulon, France