Effectiveness of Early Intervention in Palliative Care for Acute Myeloid Leukemia Patients Comparing to Standard of Care

Condition(s) studied

Investigational drug(s) / intervention(s)

Early palliative care integration: Early follow up by the palliative care team, from diagnosis

Study summary

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.

Eligibility

Primary outcome measure(s)

• Fatigue — At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
  Assessment of participant fatigue using the Fatigue Scale FACIT. The lower the score, the higher the fatigue.
• Quality of life - Functional Scale, Global Health Status, Symptom Scale — At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
  Assessment of quality of life using the questionnaire EORTC QLQ-C30. Contains 30 questions assessing three dimensions: 1) Functional Scales: The higher the score, the greater the functional level. 2) Global Health Status: The higher the score, the better the quality of life. 3) Symptom Scales: The higher the score, the greater the severity or frequency of symptoms.
• Anxiety and depression — At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
  Assessment of anxiety and depression using HADS (Hospital Anxiety and Depression Scale), composed of two subscales for anxiety and depression, each with scores categorized as normal (0-7), mild (8-10), moderate (11-14), and severe (15-21). A score ≥ 11 indicates the presence of anxiety and/or depression.
• Symptoms and multidimensional well-being — At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
  Assessment of symptoms and multidimensional well-being using the scale IPOS (Palliative care Outcome Scale). Composed by: Q1: Open-ended question, no scoring, used to guide care; Q2-Q5: Scales of 0-4, where higher scores indicate greater symptom severity; Q6-Q8: Positive items, scored 0-4, where lower scores are better; Q10: Open-ended question, no scoring. Sum of the scores from the rated questions (0-68).

Trial sites (1)

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