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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
792
Arm B : The duration of the geriatric intervention will be 12 months. The quality of life will be assessed every 3 months during the first year and at 18 months. The study's follow-up will last until 3 years after the enrollment of the last patient and data on vital status of the patient, weight, place of life and the status of the disease will be collected every 6 months.
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
Overall survival defined as the delay between randomization and death, all causes.
Time frame: Year 1
Health related quality of life (HR-QoL) assessed using 3 scales of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
Time frame: Year 1
Overall survival defined as the delay between randomization and death, all causes.
Time frame: Year 3
Health related quality of life (hRQoL) assessed using 3 scales of EORTC QLQ-C30 questionnaire.
Time frame: Year 3
6-month response rates defined as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or Cheson criteria.
Time frame: Month 6
Toxicity graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.
Time frame: up to 3 years
Number of unscheduled hospitalizations.
Time frame: up to 3 years
Length of unscheduled hospitalizations.
Time frame: up to 3 years
For the experimental arm only: Assessment of autonomy using Activities of Daily Living (ADL) questionnaire.
Time frame: Months 0, 6, 12
For the experimental arm only: Assessment of autonomy using Instrumental Activities of Daily Living (IADL) questionnaire.
Time frame: Months 0, 6, 12
For the experimental arm only: Assessment of depression using Geriatric Depression Scale (GDS-15) scale.
Time frame: Months 0, 6, 12
For the experimental arm only: Assessment of cognitive functions using mini mental state exam (MMSE).
Time frame: Months 0, 6, 12
For the experimental arm only: Assessment of comorbidities using Cumulative Illness Rating Scale for Geriatrics (CIRS-G) scale.
Time frame: Months 0, 6, 12
For the experimental arm only: Assessment of nutritional status using mini nutritional assessment (MNA) scale.
Time frame: Months 0, 6, 12
For the experimental arm only: Assessment of mobility using get-up and Go test.
Time frame: Months 0, 6, 12
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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
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