Research protocol on early palliative care in patients with acute leukaemia after one relapse

According to the American Society of Clinical Oncology palliative care referrals are made within the last 3 weeks of patients' lives and most frequently when oncological treatments have ceased especially for patients with haematological malignancies. Recent publications indicate that patients with acute leukaemia are prone to symptoms, an indication for which a close collaboration between the patient's haematologist and a palliative care team might result in improved symptom management. The object of this pilot study is to evaluate the feasibility of a clinical research trial to assess the effect of early palliative care in patients with acute leukaemia after one relapse.

This project is a multicentre, non-blinded, randomised, controlled trial. Patients in group 1 will receive standard haematological care associated with palliative care (intervention group). Patients in group 2 will receive standard haematological care with palliative care only if requested by the haematologist (control group). In order to measure an accurate sample size, patients who participate will complete a standardised questionnaire to assess their quality of life, as well as their psychological and physical symptoms, before being randomised to one of two groups in a 1:1 ratio without stratified randomisation.

The aim of this study is to analyse causes of dropout, non-adherence and missing data in order to refine the protocol for the subsequent clinical research trial.

The ultimate objective of this project is to develop collaboration between haematologists and palliative care teams in order to improve patients' quality of life.