Clinical trial · Interventional
Enhanced Palliative Care in MDS and AML
Impact of Enhanced Haematology Palliative Care Services in Patients With Myelodysplastic Syndrome and Acute Myeloid Leukaemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Care | Other | — | UNRESOLVED |
| Enhanced Haematology Palliative Care ("Fast-track") Group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enhanced Haematology Palliative Care ("Fast-track") Group
- description
- Patients who are assigned to enhanced haematology palliative care ("fast-track" group) will be seen, within 2 days of enrollment, at the out-patient clinic or in-patient setting by the haematology palliative care team that comprises a palliative medicine specialist or a haematologist with palliative care experience, a full-time palliative care nurse, and a medical social worker concentrating on haematology palliative patients.
- interventionNames
- Other: Enhanced Haematology Palliative Care ("Fast-track") Group
- type
- ACTIVE_COMPARATOR
- label
- Conventional Supportive Care Group
- description
- Patients who are assigned to the conventional supportive care group will be under care of haematologists and nurse specialists in haematology After 12 weeks of conventional supportive care, patients randomized to this group will receive services from the palliative care team and assessed every two weeks same the "fast-track" group
- interventionNames
- Other: Conventional Care
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (25)
- RESULTThol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia. Blood. 2015 Jul 16;126(3):319-27. doi: 10.1182/blood-2014-10-551911. Epub 2015 Apr 7. PMID 25852056
- RESULTJuliusson G, Antunovic P, Derolf A, Lehmann S, Mollgard L, Stockelberg D, Tidefelt U, Wahlin A, Hoglund M. Age and acute myeloid leukemia: real world data on decision to treat and outcomes from the Swedish Acute Leukemia Registry. Blood. 2009 Apr 30;113(18):4179-87. doi: 10.1182/blood-2008-07-172007. Epub 2008 Nov 13. PMID 19008455
- RESULTPrebet T, Gore SD, Esterni B, Gardin C, Itzykson R, Thepot S, Dreyfus F, Rauzy OB, Recher C, Ades L, Quesnel B, Beach CL, Fenaux P, Vey N. Outcome of high-risk myelodysplastic syndrome after azacitidine treatment failure. J Clin Oncol. 2011 Aug 20;29(24):3322-7. doi: 10.1200/JCO.2011.35.8135. Epub 2011 Jul 25. PMID 21788559
- RESULTEpstein AS, Goldberg GR, Meier DE. Palliative care and hematologic oncology: the promise of collaboration. Blood Rev. 2012 Nov;26(6):233-9. doi: 10.1016/j.blre.2012.07.001. Epub 2012 Aug 5. PMID 22874874
- RESULTManitta V, Zordan R, Cole-Sinclair M, Nandurkar H, Philip J. The symptom burden of patients with hematological malignancy: a cross-sectional observational study. J Pain Symptom Manage. 2011 Sep;42(3):432-42. doi: 10.1016/j.jpainsymman.2010.12.008. Epub 2011 Apr 7. PMID 21477979
- RESULTFadul NA, El Osta B, Dalal S, Poulter VA, Bruera E. Comparison of symptom burden among patients referred to palliative care with hematologic malignancies versus those with solid tumors. J Palliat Med. 2008 Apr;11(3):422-7. doi: 10.1089/jpm.2007.0184. PMID 18363482
- RESULTManitta VJ, Philip JA, Cole-Sinclair MF. Palliative care and the hemato-oncological patient: can we live together? A review of the literature. J Palliat Med. 2010 Aug;13(8):1021-5. doi: 10.1089/jpm.2009.0267.