Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE) (NCT02704832) | Clinical Trial Compass
CompletedNot Applicable
Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)
France792 participantsStarted 2016-09-30
Plain-language summary
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.
Who can participate
Age range70 Years
SexALL
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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
Exclusion criteria
✕. Patient who already received 2 medical treatment lines
✕. Exclusive 1st or 2nd treatment lines of :
✕. "Best supportive care" treatment
✕
What they're measuring
1
Overall survival defined as the delay between randomization and death, all causes.
Timeframe: Year 1
2
Health related quality of life (HR-QoL) assessed using 3 scales of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
. 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