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 range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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