Clinical trial NCT04226768: Enhanced Palliative Care in MDS and AML
Official title: Impact of Enhanced Haematology Palliative Care Services in Patients With Myelodysplastic Syndrome and Acute Myeloid Leukaemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic syndrome
Acute myeloid leukemia
Palliative care
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Eligibility criteria: Inclusion Criteria:

1. Myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) defined using the World Health Organization Classification 2016.
2. Patients who are able to read and respond to questions in Chinese.

Exclusion Criteria:

Patients who are already receiving care from a palliative care unit will be excluded. Patients who require immediate palliative care service, e.g. end-of-life care, will be excluded and receive palliative care immediately.

Primary outcomes:
measure: McGill Quality of Life (MQOL) Questionnaire Score
timeFrame: 24 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 24 weeks
measure: Zariet Burden Interview (ZBI)
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of admissions to acute hospital
timeFrame: 24 weeks
measure: Number of admission to intensive care unit
timeFrame: 24 weeks
measure: Overall survival
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine, the University of Hong Kong, Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Harinder Singh Harry Gill, MD
role: PRINCIPAL_INVESTIGATOR
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