Cancer Clinical Trial - Efficacy of a Systematic Referral to Palliative

Status Not yet recruiting

Clinical Trial Summary

This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers. In the standard arm, patients will be managed regardless of their PALLIA-10 score, following conventional strategy. In the experimental arm, patients will be systematically referred to a palliative care team.

Clinical Trial Description

This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers. All patients undergoing a visit in the daily emergency room of a participating center and who need for palliative management (PALLIA 10 score > 3/10) will be considered for inclusion in the PALLU study. After signing the written informed consent, patients will be randomized (1:1 ratio) in one of the following arms: - Standard arm : conventional strategy; patients will be managed regardless of their PALLIA-10 score. The need for additional care, including palliative care, will be assessed by the team in charge of the patient, as per routine practice. - Experimental arm : experimental strategy; patients will be systematically referred to a palliative care team. Randomization will be stratified according to the investigation center and pre-existing follow-up by pain management team. The difference of intervention will lie in the fact that patients will be referred or not to a palliative care team but patients from the standard arm may receive palliative care as deemed necessary by the medical oncology team. In this case, the content of palliative care for patients included in both groups will be identical. The end of the study will be the Last Patient Last Visit (LPLV), defined as the date of the 6-month visit of the last patient still alive or when the 192nd death has occurred, whichever occurs first. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06150027
Study type	Interventional
Source	Centre Leon Berard
Contact	Gisèle CHVETZOFF, MD, PhD
Phone	04 78 78 26 57
Email	gisele.chvetzoff@lyon.unicancer.fr
Status	Not yet recruiting
Phase	N/A
Start date	January 2024
Completion date	January 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers — PALLU

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms