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

Trial Summary

What is the purpose of this trial?

This research study is evaluating whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).

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 data supports the effectiveness of the treatment Primary Palliative Care for leukemia?

Research shows that integrating palliative care early in cancer treatment can improve quality of life and survival. For patients with blood cancers like leukemia, palliative care helps manage symptoms and mood, enhancing overall well-being. ^{1 2 3 4 5}

Is palliative care safe for leukemia patients?

Palliative care, which includes managing symptoms and providing support, is generally considered safe for patients, including those with leukemia. It helps improve quality of life by addressing physical and psychological needs, and studies suggest it can be integrated safely with other treatments. ^{2 5 6 7 8}

How is the palliative care treatment for leukemia different from other treatments?

Palliative care for leukemia is unique because it focuses on managing symptoms and improving quality of life alongside standard treatments, rather than just aiming to cure the disease. It involves a team approach to address physical, emotional, and spiritual needs, providing support not only to patients but also to their families and healthcare providers. ^{5 6 9 10 11}

Research Team

Areej El-Jawahri, MD

Principal Investigator

Massachusetts General Hospital

Jennifer Temel, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2021]

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

Innovations for the integration of palliative care for hematologic malignancies. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

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

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

Primary Palliative Care for Patients with Advanced Hematologic Malignancies: A Pilot Trial of the SHARE Intervention. [2020]

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

Getting comfortable with death. Palliative care begins at home. [2021]

9. China 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. [2021]

10. 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]

11. England pubmed.ncbi.nlm.nih.gov

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