Clinical trial · Interventional
Effectiveness of Early Intervention in Palliative Care for Acute Myeloid Leukemia Patients Comparing to Standard of Care
Effectiveness of Early Intervention in Palliative Care for Acute Myeloid Leukemia Patients Comparing to Standard of Care: a Randomized Pragmatic Clinical Trial, 1:1 Ratio, Parallel Group and Superiority Study
- 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)
Hemato-oncology patients undergoing intensive chemotherapy treatments experience different types of symptoms during and after treatments, which are often refractory to the established therapy. Physical symptoms such as pain, dyspnea, mucositis, insomnia, loss of appetite, constipation and diarrhea, among others, have a huge impact on quality of life, temporarily until symptomatic control, but also permanently with the development of anxiety, depression, long-term fatigue and post-traumatic stress. As recommended by ASCO (American Society of Clinical Oncology), the palliative approach to oncological diseases must be as early as possible and be part of the "standard of care". However, the lack of concrete data on this topic in the last decade served as a barrier to the early integration of this same care for hemato-oncology patients in its various areas. Palliative care presupposes global, interdisciplinary action, carried out by specific teams that must act in situations of incurable or serious illness, in an advanced and progressive phase. The potential benefits can be countless and of significant importance, from the impact on quality of life, symptomatic control, reduction of anxiety and depression and even the promotion of informed and conscious choices at the end of life as well as the reduction of aggressive strategies. used at this stage of the disease.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukaemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Palliative Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early palliative care integration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Early follow up by the palliative care team
- description
- Early follow up by the palliative care team, that is, from diagnosis
- interventionNames
- Other: Early palliative care integration
- type
- NO_INTERVENTION
- label
- Standard of care: conventional treatment
- description
- Conventional treatment by the Hematology team where this referral is made only in specific cases in which hematologists understand that this need exists.
Primary outcomes (4)
- measure
- Fatigue
- timeFrame
- At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Capable of making decisions * Diagnosed with acute myeloid leukemia * Aged 70 years or less * Treated or referred for treatment at the Hematology department of Centro Hospitalar e Universitário de São João. Exclusion Criteria: * All patients referred for "best supportive care", that is, for supportive care including treatment with cytoreductive intent.
References
Publications (0)
Data not yet available