Palliative Care for Blood Cancers

(PEACE Trial)

Overseen By Patrick C Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Impaired cognition, Uncontrolled mental illness, others

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

Compensation: Varies

Number of Visits: 4

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if adding special supportive care (PEACE) to regular cancer treatment can improve the quality of life for patients with Lymphoma, Leukemia, or Multiple Myeloma who are receiving adoptive cellular therapy. PEACE aims to help patients feel better by managing pain, symptoms, and emotional stress.

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 study team or your doctor.

What data supports the effectiveness of the treatment Palliative Care, Supportive Care, End-of-Life Care, Symptom Management, Usual Care, Standard Care, Conventional Care for blood cancers?

Research shows that integrating palliative care early in the treatment of blood cancers can improve the quality of life for patients and their caregivers. Although patients with blood cancers often receive palliative care later than those with other cancers, early integration can address specific needs like symptom control and emotional support, leading to better outcomes. ^{1 2 3 4 5}

Is palliative care safe for patients with blood cancers?

Palliative care is generally considered safe for patients with blood cancers and can help improve quality of life by managing symptoms and providing support. It is beneficial for both patients and caregivers, although it is often underused in this group of patients. ^{1 2 6 7 8}

How is palliative care different from other treatments for blood cancers?

Palliative care for blood cancers is unique because it focuses on improving quality of life by managing symptoms and providing support, rather than trying to cure the disease. Unlike other treatments, it is integrated into routine care and tailored to the specific needs of each patient, addressing both physical and psychological challenges. ^{1 2 4 8 9}

Research Team

Patrick C Johnson, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with blood cancers like Lymphoma, Leukemia, or Multiple Myeloma who are getting a special treatment called ACT at MGH and can complete surveys in English. It's not for those with cognitive issues or uncontrolled mental illness that makes it hard to follow the study rules, or those already in palliative care.

Inclusion Criteria

I have been diagnosed with a blood cancer.

I am getting a cell therapy treatment at MGH that is approved by the FDA.

Ability to complete surveys in English or with assistance of an interpreter

Exclusion Criteria

I am currently receiving care to relieve symptoms and improve quality of life.

Impaired cognition or uncontrolled mental illness that prohibits study compliance based on the oncology clinician assessment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open Pilot

10 participants with planned ACT will be enrolled into an open pilot and will receive a palliative care intervention (PEACE) for the duration of treatment.

Up to 1 year

At least 2 visits weekly during hospitalization

Randomized Treatment

Participants are randomly assigned to either the PEACE plus usual oncology care group or the usual care group.

Up to 1 year

At least 2 visits weekly during hospitalization

Follow-up

Participants will complete follow-up study assessments on pre-determined days per protocol and will be monitored for safety and effectiveness after treatment.

Up to 1 year

Remote or paper assessments

Treatment Details

Interventions

• Palliative Care
• Usual Care

Trial Overview The study tests if adding a specific type of supportive care (PEACE) to regular cancer treatment helps improve life quality for patients undergoing ACT. Participants will be randomly placed into two groups: one receiving PEACE plus usual care, and the other just usual care.

Participant Groups

Group I: Palliative Care Intervention (PEACE) Group Experimental Treatment 1 Intervention

Participants will be randomly assigned, and stratified by disease, to the PEACE Group. * Participants will meet with palliative care (PC) clinician within 1 week of T-cell collection and within 72 hours of hospital admission for ACT. * Participants will meet with PC clinician at least 2 x weekly during hospitalization. * PC clinician will follow participants up to one year after randomization (or enrollment for the open pilot) and will meet participant at least 2 x weekly during inpatient hospitalizations. * Participants will complete follow-up study assessments on pre-determined days per protocol. The assessments will be filled out remotely or via paper. * Participants will complete exit interviews in the open pilot only.

Group II: Usual Care Group Active Control 1 Intervention

Participants will be randomly assigned, and stratified by disease, to the Usual Care Group and will receive standard care for ACT.

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?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Conquer Cancer Foundation

Collaborator

Trials

22

Recruited

4,000+

Findings from Research

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]

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]

Patients with hematological malignancies often access palliative care services later in their illness compared to those with solid tumors, which can negatively impact the quality of care they receive.

Integrating palliative care earlier in the treatment process, rather than only after curative options are exhausted, can enhance patient outcomes and should involve collaboration between hematologists and palliative care specialists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care and the hemato-oncological patient: can we live together? A review of the literature. Manitta, VJ., Philip, JA., Cole-Sinclair, MF.[2015]

Patients with blood cancers experience high levels of distress and have significant palliative care needs, yet integration of palliative care in hematology is currently lacking.

To improve outcomes for patients and their families, a tailored approach to palliative care that considers the specific needs of different hematologic malignancies is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Palliative Care Integration in Hematology: Building Upon Existing Evidence. Robbins-Welty, GA., Webb, JA., Shalev, D., et al.[2023]

Early palliative care combined with standard treatment for patients with haematological cancers is an important area of research, but current studies are limited and lack robust design, with only eight articles meeting the criteria for review.

The evidence available suggests that while early palliative care may impact quality of life and resource use, the overall quality of studies is low, indicating a need for more well-designed research to better understand its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early palliative care in haematological patients: a systematic literature review. Tanzi, S., Venturelli, F., Luminari, S., et al.[2021]

Patients with hematological malignancies experience a significant symptom burden, averaging 8.8 symptoms, particularly those undergoing treatment, with poorer performance status, and advanced disease stages.

The level of distress and symptom prevalence in these patients is comparable to those with metastatic non-hematological cancers, indicating a need for comprehensive symptom assessment and potential integration of palliative care services to improve quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The symptom burden of patients with hematological malignancy: a cross-sectional observational study. Manitta, V., Zordan, R., Cole-Sinclair, M., et al.[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]

Patients with hematologic malignancies face significant physical and psychological challenges due to their illness and treatment, leading to high hospitalization rates and low hospice referrals, which negatively impacts their end-of-life care.

Integrating palliative care into the treatment of hematologic malignancies has been shown to improve quality of life for patients and caregivers, highlighting the need for more research to develop effective, population-specific palliative care interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative and End-of-Life Care for Patients With Hematologic Malignancies. El-Jawahri, A., Nelson, AM., Gray, TF., et al.[2023]

The integration of palliative care into the treatment of hematology patients is now widely accepted, shifting the focus from whether it should be included to how to implement it effectively.

Documenting the provision of medical care for these patients provides valuable baseline information that can enhance clinical practices and discussions in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haematology and palliative medicine: moving forward. McGrath, P.[2015]

References

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

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

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

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

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

Palliative care and the hemato-oncological patient: can we live together? A review of the literature. [2015]

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

Advancing Palliative Care Integration in Hematology: Building Upon Existing Evidence. [2023]

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

Early palliative care in haematological patients: a systematic literature review. [2021]

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

The symptom burden of patients with hematological malignancy: a cross-sectional observational study. [2022]

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

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

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

Palliative and End-of-Life Care for Patients With Hematologic Malignancies. [2023]

9. China pubmed.ncbi.nlm.nih.gov

Haematology and palliative medicine: moving forward. [2015]