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Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)
Randomized trials have already demonstrated that geriatric intervention was able to improve survival in the general elderly population but only a few have been performed in cancer patients. At the end, these data are not sufficient to consider geriatric intervention as validated in this setting. Case Management, coordinated by a geriatrician and a trained nurse, could improve prognosis of elderly patients with cancer. This approach, can be integrated in daily oncology practice. This strategy will be compared to usual oncological management in a randomized phase III trial.
Patients will first be screened using the G8 screening tool. If the resulting score is altered (G8 \<= 14), patients will be included in the main study and randomized according to 2 modalities: Arm A / Usual care (treatment according to on-going regimens in oncology) or Arm B /Case management (assessment of the patient by the nurse and the geriatrician with interventions as prescribed by the geriatrician). The intervention will be considered effective if, at one year, compared to usual care there is a significant clinical improvement in overall survival (OS) without a significant deterioration or/and clinical improvement of at least one of the targeted quality of life (QoL) scores, without significant clinical deterioration in at least one of the targeted QoL scores and without significant difference in OS in favor of usual care. If the resulting score is normal (G8 \> 14), patients will be treated according to their physician-in-charge opinion. A minimal set of data will be collected (age, sex, tumor type, disease stage, performance status (PS), creatinine clearance, albumin and C-Reactive Protein (CRP) levels mainly) to allow for the characterization of the population in order to compare our results to those of other published series.
Age
70 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre Hospitalier Universitaire de Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
Institut de Cancérologie de l'Ouest
Angers, France
Centre Hospitalier de Beauvais
Beauvais, France
Clinique Anne d'Artois
Béthune, France
Institut Bergonié Centre Régional de Lutte Contre le Cancer
Bordeaux, France
CHU de Bordeaux
Bordeaux, France
Centre Hospitalier Universitaire de Caen
Caen, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, France
Centre Hospitalier Intercommunal de Castres Mazamet
Castres, France
Centre Hospitalier Métropôle Savoie Chambéry
Chambéry, France
Start Date
September 30, 2016
Primary Completion Date
December 31, 2023
Completion Date
November 21, 2025
Last Updated
January 30, 2026
792
ACTUAL participants
Geriatrician Intervention
OTHER
Lead Sponsor
Institut Bergonié
Collaborators
NCT06498635
NCT05692635
Data Source & Attribution
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