Impact of enhanced haematology palliative care services in patients with myelodysplastic syndrome and acute myeloid leukaemia: study protocol for a randomized controlled trial.

Abstract

BACKGROUND\nPatients with acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) suffer from a significant symptom burden and psychological, spiritual, social needs comparable to patients with solid metastatic malignancy. Referral to palliative care services for these haematological patients remains limited or often confined to the last days of life. We pioneered a palliative care (PC) program integrated with standard haematological care. The purpose of this trial will study the interventions by the PC team and preliminary results in the clinical outcomes.\n\n\nMETHODS\nThis project is a non-blinded, randomized, controlled trial. In this study, we examine the clinical outcomes of the integrated PC program for MDS/AML patients when the 2nd lines disease treatment failed and in the presence of prognostic indicators. In group 1, patients will receive standard haematological care associated with PC (i.e., intervention group). In contrast, in group 2, patients will receive standard haematological care only (i.e., control group) with PC service only on a request basis. Patients who join the program would have to complete a standardized questionnaire to assess their quality of life and their psychological and physical symptoms.\n\n\nRESULTS\nThis is to exam the impact of the early integrated palliative care with enhanced psychosocial interventions to both advanced MDS/AML patients and their primary family members in Hong Kong.\n\n\nDISCUSSION\nThis protocol will not display any result. If future results demonstrate that the enhanced PC interventions are effective, they will provide a quality treatment plan for patients with MDS/AML.\n\n\nTRIAL REGISTRATION\nThe Hong Kong University/Hospital Authority Hong Kong West Institutional Review Board (HKU/HA HKW IRB). The registration number is UW 19-824.