NCT04226768

Enhanced Palliative Care in MDS and AML

Impact of Enhanced Haematology Palliative Care Services in Patients With Myelodysplastic Syndrome and Acute Myeloid Leukaemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Objectives: The purpose of this study is to evaluate the impact of enhanced haematology palliative care services to the most symptomatic group of blood cancer patients, namely myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML). Hypothesis to be tested: To test whether early integration of dedicated palliative care will improve the quality of life, mood and caregiver burden in patients with MDS and AML. Design and subjects: This is a 24-month open-label randomized controlled trial. Subjects include patients with MDS and AML. Study instruments: Interventions will be carried out by a dedicated team comprising palliative care physicians, haematologists, palliative care nurse specialists, and social workers. Outcome measures will be determined using validated questionnaires and data collection tools. Interventions: In this trial, enhanced haematology palliative care integrated to conventional supportive care versus conventional supportive care alone will be compared. Main outcome measures: The primary outcome measures include quality of life, mood and caregiver burden. The secondary outcome measures include number of admissions to acute hospital and intensive care and overall survival.

Detailed description

Acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) are heterogeneous haematological malignancies associated with guarded long-term outcomes. In AML, 5-year overall survivals is approximately 40% even in young patients. Relapsed or refractory state is seen in up to 40% of patients with AML is associated with a poor outlook especially in patients in-eligible for intensive treatment. MDS is rarely curable except in young patients eligible for allogeneic haematopoietic stem transplantation (HSCT). MDS failing initial treatment have median survivals of less than 6 months. Most patients with AML and MDS are diagnosed after the age of 65, making them physically-ineligible for intensive curative treatment such as HSCT. In addition to inferior survivals, most patients with relapsed or refractory AML and MDS have profound cytopenia resulting in increased risk of infections and need for frequent blood product support. Quality of life (QOL) is affected due to significant symptom burden, treatment side-effects and repeated admission. Furthermore, an increased caregiver burden could be anticipated. Patients with blood cancers, especially those with AML and MDS experience significant physical and psychological symptoms that are comparable to or exceeding that seen in patients with solid organ cancers. Well-designed randomized controlled trials have clearly demonstrated the benefits of integrating early palliative care concurrently with standard care in cancer patients. Most of these trials demonstrated improved QOL and mood as well as reduction in the utilization of healthcare services. It is now recommended that in-patients and out-patients with advances malignancies should receive dedicated palliative care services early during the course of the disease. Caregivers may also be referred for palliative services to reduce caregiver burden. Despite the need for specific palliative care services, growing literature suggests that patients with blood cancer are less likely to receive palliative care services early. We have also shown that most patients with AML receive palliative care late and spend most the end-of-life periods in acute hospitals. In addition, there is a lack of studies examining the impact of early dedicated multidisciplinary palliative care services on blood cancer patients' QOL, mood and caregiver burden. In this study, investigators designed an open-label randomized controlled-study comparing early enhanced palliative care serviced versus usual care in patients with myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
OTHER	Enhanced Haematology Palliative Care ("Fast-track") Group	Early and proactive multidisciplinary care
OTHER	Conventional Care	Conventional care and referral as indicated

Timeline

• Start date: 2020-01-09
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2020-01-13
• Last updated: 2022-10-04

Locations

1 site across 1 country: Hong Kong