Clinical trial NCT06848270: Effectiveness of Early Intervention in Palliative Care for Acute Myeloid Leukemia Patients Comparing to Standard of Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Palliative Care
Acute Myeloid Leukaemia
Keywords: Acute myeloid leukaemia
Palliative care
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar De São João, E.P.E.
First posted: 2025-02-27
Enrollment: 50
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized pragmatic clinical trial, 1:1 ratio, parallel group and superiority study that compares the effectiveness of early intervention of palliative care in acute myeloid leukemia patients comparing to standard of care.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Hematological diseases are biologically complex and constitute a group of oncological pathologies in which the acute disease has an unpredictable course and can reach different outcomes quickly. Patients often experience rapid and not always predictable progression during their treatment trajectory and at the end of life. Unlike most advanced solid tumors, the possibility of cure remains an objective even in situations of relapse or refractory disease. 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. There are still many specific needs that have not been identified, especially in the initial approach to acute illness. 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 palliative approach can begin with palliative actions carried out by professionals without specific training so that, in inpatient or outpatient settings, the negative repercussions of the disease can be reduced on the various aspects of the patient: physical, psychological, social and spiritual. To this end, palliative interventions must be developed and defined based on the greatest needs of this population and the timing of the disease, not just at the end of life. 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.

The still scarce knowledge among hematologists about the benefits of palliative care in this population has represented an important barrier. In intensive chemotherapy, area of palliative care that have been little intervened, there seems to be an enormous potential for benefit with these interventions given the complexity of physical and psychological symptoms involved, with "cure" being the main objective. Our aim is to evaluate the effect of early follow-up by the palliative care team compared to conventional treatment by the Hematology team, where this referral is made only in specific cases.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue
timeFrame: At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
measure: Quality of life - Functional Scale, Global Health Status, Symptom Scale
timeFrame: At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
measure: Anxiety and depression
timeFrame: At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
measure: Symptoms and multidimensional well-being
timeFrame: At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar e Universitário de São João
Study officials:
References: