Palliative Care for Leukemia

Overseen By Katherine Murphy

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Virginia

Disqualifiers: Acute promyelocytic leukemia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to estimate the potential benefit of early and continued palliative care (PC) consultation on end of life issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Palliative Care, Supportive Care, End-of-Life Care, Symptom Management for leukemia?

Research shows that early integration of palliative care with standard treatment for leukemia can help manage painful symptoms and improve the quality of life for patients. It also highlights the benefits of palliative care in reducing unnecessary suffering and providing better support for both patients and caregivers. ^{1 2 3 4 5}

Is palliative care safe for leukemia patients?

Palliative care, which focuses on improving quality of life and managing symptoms, is generally considered safe for leukemia patients. It has been shown to improve quality of life and psychological outcomes when integrated early with standard leukemia care. ^{4 5 6 7 8}

How is palliative care different from other treatments for leukemia?

Palliative care for leukemia focuses on relieving symptoms and improving quality of life rather than curing the disease. It is unique because it addresses not only physical symptoms but also emotional, social, and spiritual needs, providing support to both patients and their families throughout the illness. ^{2 3 5 9 10}

Research Team

Karen Ballen, MD

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for adults aged 18 and older with a new or relapsed diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). Participants must be able to consent, follow the study plan, and not have Acute Promyelocytic Leukemia.

Inclusion Criteria

I am 65 or older with a new diagnosis of AML, ALL, high-risk MDS, or high-risk CMML.

I am 18 or older with a specific type of blood cancer that has not responded to treatment.

My leukemia has not responded to at least two rounds of chemotherapy.

Exclusion Criteria

I do not have Acute Promyelocytic Leukemia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group will have regular visits with a palliative care specialist, twice a week in the hospital and about every other week out of the hospital. Monthly questionnaires will be completed.

2 years

Twice a week (in-hospital), every other week (out-of-hospital)

Standard Care

Participants in the standard care group will see a palliative care specialist only if referred by their oncologist. Monthly questionnaires will be completed.

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including emergency department visits, hospice services use, and quality of life measures.

2 years

Treatment Details

Interventions

• Palliative Care

Trial Overview The trial studies the impact of early and ongoing palliative care consultations on end-of-life issues for patients with certain high-risk leukemias or MDS. It aims to understand how this supportive care can benefit these individuals.

Participant Groups

Group I: Palliative Care Intervention Experimental Treatment 1 Intervention

Participants on this arm will see a palliative care specialist twice a week while they are in the hospital and about every other week when they are out of the hospital. If participants see their oncologist less often than every other week while they're out of the hospital, then visits with the palliative care specialist would be timed to occur on the same day as the oncologist visit. Participants will complete a questionnaire about once a month.

Group II: Standard Clinical Care Active Control 1 Intervention

Participants will see a palliative care specialist only if they have a referral from their oncologist according to standard clinical care. Participants on this arm will not be discouraged from requesting a consult.

Palliative Care is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Palliative Care for:

• Symptom management for various conditions including cancer, neurological disorders, and end-of-life care

Approved in United States as Palliative Care for:

• Symptom management for various conditions including cancer, neurological disorders, and end-of-life care

Approved in Canada as Palliative Care for:

• Symptom management for various conditions including cancer, neurological disorders, and end-of-life care

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Findings from Research

Palliative care has been shown to provide significant benefits for patients with hematologic malignancies and their caregivers, yet there is a notable gap in its integration into standard cancer care.

There is a pressing need for innovative models to integrate palliative care early in the treatment process for patients with hematologic malignancies, addressing their unique needs based on disease subtype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care for patients with hematologic malignancies: are we meeting patients' needs early enough? Kayastha, N., LeBlanc, TW.[2022]

Integrating hematologists with palliative care specialists and pain therapists early in the treatment of acute leukemia can significantly improve patient management and reduce painful symptoms.

This collaborative approach aims to minimize unnecessary suffering and enhance the overall outcomes for patients undergoing intensive or novel treatments, addressing their complex clinical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain and related complaints in patients with acute leukemia: time for simultaneous care in hemato-oncology. Niscola, P., Tendas, A., Mazzone, C., et al.[2019]

Palliative care is increasingly recognized as essential throughout the course of illness, yet patients with haematological malignancies often receive it later than those with other cancers, highlighting a need for earlier integration.

Effective communication and tailored strategies are crucial for providing palliative care to patients with haematological malignancies, considering their unique treatment needs and the complexities of their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care of patients with haematological malignancies: strategies to overcome difficulties via integrated care. Wedding, U.[2022]

In a study of 215 patients with acute myeloid leukaemia receiving early palliative supportive care, over 50% met four or more quality indicators for palliative care, indicating effective implementation of supportive measures.

Patients receiving early palliative care showed low rates of aggressive treatments at the end of life, with only 2.7% undergoing chemotherapy in the last 14 days and many dying at home or in hospice, suggesting a focus on comfort rather than intensive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early palliative/supportive care in acute myeloid leukaemia allows low aggression end-of-life interventions: observational outpatient study. Potenza, L., Scaravaglio, M., Fortuna, D., et al.[2021]

A survey of 425 nurses across 26 hematology wards revealed that they generally rated the care provided to leukemia patients as inadequate, particularly in addressing social distress.

The study highlighted the importance of improving communication among healthcare professionals, better utilization of hospital resources, and enhancing palliative care education for staff to improve care for leukemia patients in the incurable phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurses' perception of adequacy of care for leukemia patients with distress during the incurable phase and related factors. Shirai, Y., Kawa, M., Miyashita, M., et al.[2018]

Patients with acute myeloid leukemia (AML) experience significant challenges such as physical symptoms, psychological distress, and uncertainty about their prognosis, indicating a strong need for palliative care interventions.

The study, which involved interviews with 22 AML patients approximately 3 months after intensive chemotherapy, identified specific issues like feelings of helplessness, fatigue, and caregiver stress, highlighting opportunities for targeted palliative care to address these unmet needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Leukemia Patients' Needs: Qualitative Findings and Opportunities for Early Palliative Care. Boucher, NA., Johnson, KS., LeBlanc, TW.[2019]

Acute myeloid leukemia (AML) is the most common acute leukemia in adults, and while supportive measures can help initially, disease-directed therapy is often necessary, even at the end of life, which can complicate symptom management.

Integrating early palliative care with standard leukemia treatment has been shown to improve quality of life and psychological outcomes for AML patients, as well as enhance participation in advance care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Top Ten Tips Palliative Care Clinicians Should Know About Acute Myeloid Leukemia. Patel, RV., Ali, F., Chiad, Z., et al.[2023]

In a study of 92 pediatric patients with hematologic malignancies, there were a total of 522 identified 'palliative opportunities' for integrating palliative care, which increased as patients approached end-of-life.

Despite the high number of palliative opportunities, 70.3% occurred without palliative care consultation, highlighting a significant gap in support that could improve the quality of life for these patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating palliative opportunities in pediatric patients with leukemia and lymphoma. Labudde, EJ., DeGroote, NP., Smith, S., et al.[2021]

Palliative care is essential for patients with hematologic malignancies, addressing their physical, emotional, and spiritual needs, especially given the significant symptom burden and quality of life challenges associated with these illnesses.

Evidence shows that integrating palliative care with curative or life-prolonging treatments can lead to better outcomes for patients, yet barriers such as confusion about palliative care's role and lack of training for healthcare providers hinder its routine implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care and hematologic oncology: the promise of collaboration. Epstein, AS., Goldberg, GR., Meier, DE.[2012]

Patients with hematological malignancies experience a significant disease burden similar to those with solid tumors, yet they are often underrepresented in palliative care due to unique care needs and prognostic uncertainties.

Recent studies have highlighted the importance of interdisciplinary collaboration and the need for effective communication in palliative care for these patients, suggesting that future research should focus on patient perspectives and tailored support models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific challenges in end-of-life care for patients with hematological malignancies. Gerlach, C., Alt-Epping, B., Oechsle, K.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Palliative care for patients with hematologic malignancies: are we meeting patients' needs early enough? [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Pain and related complaints in patients with acute leukemia: time for simultaneous care in hemato-oncology. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Palliative care of patients with haematological malignancies: strategies to overcome difficulties via integrated care. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Early palliative/supportive care in acute myeloid leukaemia allows low aggression end-of-life interventions: observational outpatient study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Nurses' perception of adequacy of care for leukemia patients with distress during the incurable phase and related factors. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Acute Leukemia Patients' Needs: Qualitative Findings and Opportunities for Early Palliative Care. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Top Ten Tips Palliative Care Clinicians Should Know About Acute Myeloid Leukemia. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluating palliative opportunities in pediatric patients with leukemia and lymphoma. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Palliative care and hematologic oncology: the promise of collaboration. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Specific challenges in end-of-life care for patients with hematological malignancies. [2020]