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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether early and ongoing palliative care (supportive care) can help individuals with certain types of leukemia manage end-of-life issues more effectively. It compares regular palliative care visits to seeing a specialist only upon referral by an oncologist. Participants will either see a palliative care specialist regularly or only as needed, based on their doctor's advice. Suitable candidates include those with a new or relapsed diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or high-risk myelodysplastic syndromes (MDS), who notice their condition is not improving after treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

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 prior data suggests that palliative care is safe for leukemia patients?

Research has shown that palliative care is generally safe for people with leukemia. In studies, patients who received early palliative care tolerated it well, with few reports of serious side effects. Most patients found it helped manage pain and other symptoms like tiredness and nausea. These findings suggest that palliative care can improve quality of life without adding significant risks. For those considering this option, it's important to know that many patients benefit from the regular support and symptom management provided by palliative care specialists. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a more integrated approach to palliative care for leukemia patients. Unlike standard care, where palliative services are usually accessed only through oncologist referral, this new method provides regular, proactive palliative care consultations. Patients have scheduled visits with a palliative care specialist twice a week in the hospital and about every other week outside, aligning with oncologist visits. This proactive approach aims to enhance quality of life by addressing symptoms and emotional needs more consistently and promptly.

What evidence suggests that palliative care might be an effective treatment for leukemia?

Research has shown that starting and continuing palliative care early can greatly improve the quality of life for people with leukemia. In studies involving adults with acute myeloid leukemia (AML), palliative care improved patients' perceptions of their quality of life and reduced symptoms such as depression and anxiety. Patients also reported better experiences with end-of-life care. This trial will compare two approaches: one group will receive a structured palliative care intervention, while the other will receive standard clinical care, where palliative care is provided only with a referral. This type of care addresses both physical and emotional needs, leading to a more comprehensive care experience. Overall, adding palliative care early in treatment offers clear benefits for those dealing with serious illnesses like leukemia. ^{1 6 7 8 9}

Who Is on the Research Team?

Karen Ballen, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33331857/

Effectiveness of Integrated Palliative and Oncology Care for ... In this randomized clinical trial of patients with AML, IPC led to substantial improvements in QOL, psychological distress, and EOL care.

2. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2773838

Effectiveness of Integrated Palliative and Oncology Care ... In this randomized clinical trial of 160 adults with AML, IPC improved patient-reported quality of life, as well as depression, anxiety, and posttraumatic ...

3. apm.amegroups.org apm.amegroups.org/article/view/141144/html

Palliative care interventions and their early integration in the ... Background and Objective: Palliative care (PC) interventions have become essential in treating patients with acute myeloid leukemia (AML).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8462532/

Palliative and End-of-Life Care for Patients With ... Early integration of specialty palliative care has been shown to improve a wide range of outcomes for patients with advanced solid tumors, including QOL, mood, ...

5. jpsmjournal.com jpsmjournal.com/article/S0885-3924(24)00960-6/fulltext

Palliative Care in Hematology: A Systematic Review of the ... This systematic review aims to provide an overview of the intervention components, the targeted outcomes, the effectiveness in improving patient and informal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8833517/

Early Palliative Care in Acute Myeloid Leukemia - PMC EPC patients demonstrated high rates of receiving quality palliative care. All of them received assessment and management of pain, more than 70% ...

7. spcare.bmj.com spcare.bmj.com/content/14/e1/e1111

Early palliative/supportive care in acute myeloid leukaemia ... Results 131 patients received a full early palliative supportive care intervention. All patients had at least one and 67 (51%) patients had four or more quality ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12221262/

Quality indicators and patient outcome measures for ... The objective of this systematic review is to assess the QIs and POMs used to evaluate palliative care service on aggregated and individual levels.

9. ascopubs.org ascopubs.org/doi/10.1200/EDBK_432196

Integrating Palliative Care and Hematologic Malignancies Hospitalized patients with acute leukemia report up to 13 physical symptoms, including fatigue, dry mouth, nausea, and sleep disturbance, as ...