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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patient older 70 years and older
Performance status 0 to 3 (WHO)
G8 and QLQ-C30 questionnaires 'score are available
No previous geriatric evaluation during cancer treatment
Locally advanced or metastatic disease :
1st line medical treatment :
Or 2nd line medical treatment :
Life expectancy over 6 months
Signed informed consent
Patients with a French social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code).
Exclusion criteria
Patient who already received 2 medical treatment lines
Exclusive 1st or 2nd treatment lines of :
"Best supportive care" treatment
Patient unable to understand quality of life questionnaire
Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
Patient placed under guardianship
Planned concomitant participation to another medical interventional trial during the 12 months following the inclusion in the randomized study PREPARE
Previous enrolment in the present study
Primary purpose
Allocation
Interventional model
Masking
792 participants in 2 patient groups
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Central trial contact
Caroline LALET; Pierre-Louis SOUBEYRAN, PU-PH
Data sourced from clinicaltrials.gov
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