Palliative Care Delivery for Leukemia

(SCOPE-L Trial)

Recruiting at 19 trial locations

Overseen By Areej El-Jawahri, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Chemotherapy, Hypomethylating agents

Disqualifiers: Acute promyelocytic leukemia, Psychiatric conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 weeks

2300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether primary palliative care, which provides basic supportive care, can match the effectiveness of specialty palliative care in enhancing life quality, symptoms, mood, coping, and end-of-life experiences for individuals with acute myeloid leukemia (AML). It compares two types of palliative care, focusing on comfort and quality of life. The trial seeks patients hospitalized with high-risk AML who have just begun treatment, such as intense chemotherapy or similar therapies. A close adult friend or family member who visits at least twice a week may also qualify to participate as a caregiver in this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving supportive care for AML patients.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these palliative care strategies are safe for leukemia patients?

Research has shown that palliative care, whether basic or specialized, is generally safe and well-tolerated by patients with acute myeloid leukemia (AML). Studies indicate that starting palliative care early can effectively manage symptoms like pain, tiredness, and nausea.

For basic palliative care, over 70% of patients in past studies reported effective pain relief, suggesting that this care is safe and helps improve comfort.

Specialized palliative care has also improved symptom management and reduced stress. This type of care focuses on enhancing the quality of life for those with serious illnesses.

Both basic and specialized palliative care aim to relieve symptoms and provide emotional support, with past studies confirming their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches to palliative care for leukemia patients: Primary Palliative Care and Specialty Palliative Care. Unlike standard treatments that primarily focus on directly combating leukemia, these approaches aim to improve the overall quality of life and provide holistic support for patients. Primary Palliative Care is integrated into the general medical care team, making it more accessible, while Specialty Palliative Care involves a dedicated team of specialists providing more focused support. This trial hopes to uncover which method is more effective in enhancing patient well-being, potentially transforming how palliative care is delivered to leukemia patients.

What evidence suggests that this trial's treatments could be effective for improving quality of life in patients with acute myeloid leukemia?

Research has shown that both basic and specialized palliative care can significantly enhance the quality of life for patients with acute myeloid leukemia (AML). In this trial, participants will receive either Primary Palliative Care or Specialty Palliative Care. Studies indicate that combining palliative care with cancer treatment results in a better quality of life than standard care alone. Specialized palliative care manages symptoms, reduces stress, and improves end-of-life experiences. These treatments focus on alleviating symptoms and stress from serious illness, helping patients feel better emotionally and physically. By addressing these needs, both basic and specialized palliative care offer promising benefits for those battling AML. ^{2 6 7 8 9}

Who Is on the Research Team?

Areej El-Jawahri, MD

Principal Investigator

Massachusetts General Hospital

Jennifer Temel, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for hospitalized adults with high-risk acute myeloid leukemia (AML), including those newly diagnosed over 60, with a related prior blood disorder, treatment-related disease, or relapsed/refractory AML. They must be undergoing intensive chemotherapy or treatments requiring prolonged hospitalization. Excluded are patients with acute promyelocytic leukemia, receiving only supportive care, or unable to consent due to psychiatric/cognitive conditions.

Inclusion Criteria

I am an adult who lives with or sees the patient at least twice a week.

I am 60 years or older with a new diagnosis.

I am undergoing intensive chemotherapy or treatment with hypomethylating agents.

Exclusion Criteria

I have been diagnosed with acute promyelocytic leukemia.

I am receiving only supportive care for my AML.

Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either specialty or primary palliative care during their hospital stays for AML

Up to 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Primary Palliative Care
• Specialty Palliative Care

Trial Overview The study compares primary palliative care—comfort care provided by the patient's usual healthcare team—with specialty palliative care given by experts in symptom management and emotional support. It aims to see which approach better improves quality of life, symptoms control, mood stabilization, coping abilities and end-of-life outcomes for AML patients.

How Is the Trial Designed?

Group I: Specialty Palliative Care Experimental Treatment 1 Intervention

\- Participants will complete baseline self-report assessments at the time of informed consent

Group II: Primary Palliative Care Experimental Treatment 1 Intervention

\- Participants will complete baseline self-report assessments at the time of informed consent

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Palliative care is essential for patients with life-limiting diseases, as it addresses both physical and psychological symptoms while also supporting caregivers, ensuring comprehensive management alongside active disease treatment.

All physicians, including primary care and specialists, are encouraged to provide primary palliative care, which includes discussing goals of care and end-of-life wishes, highlighting its importance in improving patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting comfortable with death. Palliative care begins at home. Honeycutt, PJ., Bickel, D.[2021]

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]

This study is testing an integrated palliative care program for patients with acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) to see if it improves their quality of life and addresses their psychological and physical symptoms, compared to standard care alone.

The trial involves a randomized controlled design with patients receiving either standard haematological care plus palliative care or standard care only, aiming to provide insights into the benefits of early palliative interventions for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of enhanced haematology palliative care services in patients with myelodysplastic syndrome and acute myeloid leukaemia: study protocol for a randomized controlled trial. Chan, KY., Gill, H., Li, CW., et al.[2021]

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]

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]

A nurse-led primary palliative care intervention was developed and tested for patients with advanced hematologic malignancies, showing that 69% of patients and 100% of caregivers felt it helped them understand the illness and cope better.

While the intervention was well-received by caregivers and oncologists, the study faced challenges with enrollment, indicating that future efforts should focus on enhancing patient and clinician involvement to improve feasibility and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Palliative Care for Patients with Advanced Hematologic Malignancies: A Pilot Trial of the SHARE Intervention. Resick, JM., Sefcik, C., Arnold, RM., et al.[2020]

This study will assess the impact of 'Enhanced Supportive Care', an early palliative care intervention provided by nurses, on the quality of life and symptoms of 360 advanced cancer patients undergoing chemotherapy, with evaluations at 3 and 6 months.

The trial aims to provide evidence on how early palliative care can improve not only patient outcomes, such as coping and depression, but also the well-being of caregivers, potentially enhancing overall cancer care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial. Choi, YY., Rha, SY., Cho, S., et al.[2022]

A study of 459 cancer patients showed that adherence to specific palliative care quality measures, like timely pain management and emotional well-being assessments, is linked to improved quality of life, especially for older patients.

In multivariate analysis, factors such as performance status and comprehensive symptom screening were significant predictors of high quality of life, suggesting that integrating supportive care into oncology can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conformance with supportive care quality measures is associated with better quality of life in patients with cancer receiving palliative care. Kamal, AH., Bull, J., Stinson, CS., et al.[2021]

Integrated specialist palliative care significantly improves symptom burden, mood, and quality of life for patients with hematologic malignancies, benefiting both patients and their caregivers.

Despite these benefits, many patients with hematologic malignancies do not access palliative care until late in their disease, highlighting a critical need for earlier integration of palliative services into cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations for the integration of palliative care for hematologic malignancies. Kayastha, N., Kavanaugh, AR., Webb, JA., et al.[2023]

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]

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]

Citations

1. cpd.partners.org cpd.partners.org/content/october-25-2023-addressing-palliative-care-needs-patients-acute-myeloid-leukemia-aml-primary

October 25, 2023 Addressing the Palliative Care Needs of ... The goal of the trial is to answer a critical question on how to best address the palliative care needs of patients with AML and their ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7747042/

Effectiveness of Integrated Palliative and Oncology Care ... When compared with patients assigned to usual care, patients assigned to integrated palliative and oncology care reported better quality of life ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05237258

Study Details | NCT05237258 | Specialty Compared to ... This research study is evaluating whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.17_suppl.LBA6508

Multi-site randomized trial of a collaborative palliative and ... We conducted a multi-site randomized clinical trial of a collaborative palliative and oncology care model compared to usual care in 115 adult patients with AML ...

5. scholars.duke.edu scholars.duke.edu/publication/1468963

Effectiveness of Integrated Palliative and Oncology Care for ... IMPORTANCE: Patients with acute myeloid leukemia (AML) receiving intensive chemotherapy experience substantial decline in their quality of life (QOL) and ...

6. 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).

7. 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% ...

8. 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 ...

9. 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 ...