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

NCT06848270 | Not Yet Recruiting

• 1 other identifier: Acute myeloid leukemia
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care; Acute Myeloid Leukaemia

Keywords

Acute myeloid leukaemia; Palliative care

Outcome Measures

Primary Outcomes (4)

• Fatigue

  Assessment of participant fatigue using the Fatigue Scale FACIT. The lower the score, the higher the fatigue.

  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.

  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.

  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).

  At diagnosis/start of treatment; After induction cycle (approximately after 1 month); After consolidation cycles (approximately after 2 and 3 months)

Study Arms (2)

Early follow up by the palliative care team

ACTIVE COMPARATOR

Early follow up by the palliative care team, that is, from diagnosis

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.

Interventions

Early palliative care integration OTHER

Early follow up by the palliative care team, from diagnosis

Early follow up by the palliative care team

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• All patients referred for "best supportive care", that is, for supportive care including treatment with cytoreductive intent.

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar De São João, E.P.E.: collaborator

Study Sites (1)

Centro Hospitalar e Universitário de São João

Porto, 4200-319, Portugal

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Rita Damas, MD

CONTACT

+351 917312684; ritaisabeldamas@gmail.com

Janete Santos, PhD

CONTACT

+351 225 513 600; investigaclinica@med.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 27, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)