Palliative CareNCT06848270
Effectiveness of Early Intervention in Palliative Care for Acute Myeloid Leukemia Patients Comparing to Standard of Care
A study testing Early palliative care integration in people with Palliative Care and Acute Myeloid Leukaemia, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Palliative Care, Acute Myeloid Leukaemia
- What is being tested?
- Early palliative care integration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- All patients referred for "best supportive care", that is, for supportive care including treatment with cytoreductive intent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Palliative Care, Acute Myeloid Leukaemia
- Being tested
- Early palliative care integration
- Keywords
- Acute myeloid leukaemia, Palliative care
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early palliative care integrationOther
Early follow up by the palliative care team, from diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Early follow up by the palliative care team | Active comparator | Early follow up by the palliative care team, that is, from diagnosis Receives: Other: Early palliative care integration |
| Standard of care: conventional treatment | No intervention | Conventional treatment by the Hematology team where this referral is made only in specific cases in which hematologists understand that this need exists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Assessment of participant fatigue using the Fatigue Scale FACIT. The lower the score, the higher the fatigue.
Measured: At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
Quality of life - Functional Scale, Global Health Status, Symptom Scale
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.
Measured: At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
Anxiety and depression
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.
Measured: At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
Symptoms and multidimensional well-being
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).
Measured: At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848270
- Sponsor's protocol ID
- Acute myeloid leukemia
- Status last verified
- Jan 2025
- First submitted
- 3 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06848270
- Acronym / sponsor ID
- Acute myeloid leukemia
- Conditions
- Palliative Care, Acute Myeloid Leukaemia
- Keywords
- Acute myeloid leukaemia, Palliative care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E.
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early follow up by the palliative care team | Active comparator | Other: Early palliative care integrationEarly follow up by the palliative care team, that is, from diagnosis |
| Standard of care: conventional treatment | No intervention | –Conventional treatment by the Hematology team where this referral is made only in specific cases in which hematologists understand that this need exists. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- All patients referred for "best supportive care", that is, for supportive care including treatment with cytoreductive intent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early palliative care integrationEarly follow up by the palliative care team, from diagnosis | Other | Early follow up by the palliative care team |
Primary outcome
Fatigue
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early palliative care integration in people with Palliative Care and Acute Myeloid Leukaemia, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rita Damas, MD (+351 917312684, ritaisabeldamas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.