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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding palliative care, which focuses on comfort and quality of life, benefits people with blood cancers such as Lymphoma, Leukemia, or Multiple Myeloma who are receiving adoptive cellular therapy (ACT). Participants will either receive this additional palliative care alongside their usual cancer treatment or only their usual cancer treatment. The trial seeks to discover if the extra care improves participants' quality of life. Individuals with a blood cancer diagnosis, who can complete surveys in English, and are receiving ACT at MGH may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore additional supportive care options that may enhance quality of life during treatment.

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 prior data suggests that the palliative care intervention (PEACE) is safe for participants with blood cancers?

Research has shown that palliative care is generally well-tolerated by patients with blood cancers such as leukemia, lymphoma, and multiple myeloma. Studies have found that adding palliative care can lead to better outcomes, including improved quality of life. Palliative care is not a drug or surgery; it focuses on managing symptoms and providing support, which can be very helpful.

Regarding safety, no major risks are linked to palliative care. It is designed to make patients more comfortable and manage symptoms, helping them feel better without causing harm. Most people experience positive effects, such as less pain and better emotional support.

Overall, palliative care is considered safe and can be an important part of the treatment plan for those receiving adoptive cellular therapy (ACT) for blood cancers. It aims to make the treatment journey more comfortable and improve the overall experience for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how integrating palliative care into the treatment of blood cancers might improve patient outcomes. Unlike the standard care that primarily focuses on treating the cancer itself, the palliative care intervention aims to enhance the quality of life by addressing physical, emotional, and psychological needs. This approach involves frequent, personalized support from palliative care clinicians throughout the treatment process, including regular follow-ups even after hospital discharge. By focusing on comprehensive care, researchers hope to discover whether this method can offer better support and improve overall well-being for patients with blood cancers.

What evidence suggests that the PEACE intervention could improve quality of life for patients with blood cancers?

Research has shown that palliative care, which participants in this trial may receive as part of the Palliative Care Intervention (PEACE) Group, can greatly improve the quality of life for patients with blood cancers like lymphoma, leukemia, and multiple myeloma. These patients often face frequent hospital visits and require extensive medical care. However, adding palliative care helps them manage symptoms more effectively and reduces stress during treatment. Although most research has focused on solid tumors, evidence indicates that people with blood cancers also benefit from this supportive care. Patients receiving palliative care often report feeling better and having a more positive healthcare experience. ^{1 6 7 8 9}

Who Is on the Research Team?

Patrick C Johnson, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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 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]

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]

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]

Citations

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

Palliative and End-of-Life Care for Patients With ... Compared with patients with solid tumors, those with hematologic malignancies also experience high rates of hospitalizations, intensive care unit admissions, ...

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

Palliative Care in Hematology: A Systematic Review of the ... However, most research on the integration of PC in cancer care has focused on patients with solid tumors, often to the exclusion of patients ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00081

Palliative and End-of-Life Care in Hematologic Malignancies Unfortunately, compared with their counterparts with solid tumors, adults with hematologic malignancies have lower rates of hospice referrals, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10911781/

Palliative Care in Patients with Hematological Malignancies Patients with hematological malignancies have different disease findings compared to solid tumors when palliative and end-of-life care needs are evaluated ( ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0885392421002384

Outcomes of Specialty Palliative Care Interventions for ... Unlike oncology patients, hematology patients who present with very advanced malignancies may be cured with anti-cancer therapy; they may also have rapid and ...

6. ascopubs.org ascopubs.org/doi/10.1200/EDBK_432196

Integrating Palliative Care and Hematologic Malignancies While specialty palliative care has been shown to improve a wide range of outcomes for patients with solid tumors, disease-, clinician-, and ...

7. apm.amegroups.org apm.amegroups.org/article/view/102794/html

Supportive care and symptom management in patients with ... Palliative and End-of-Life Care for Patients With Hematologic Malignancies. ... Safety and efficacy for patients with hematologic malignancies.

8. ashpublications.org ashpublications.org/bloodadvances/article/4/15/3606/461718/End-of-life-care-quality-outcomes-among-Medicare

End-of-life care quality outcomes among Medicare ... Patients with hematologic malignancies are thought to receive more aggressive end-of-life (EOL) care and have suboptimal hospice use compared with patients ...

9. mdpi.com mdpi.com/2227-9032/13/21/2789

Early Palliative Care in Advanced Hematologic Malignancies Early Palliative Care in Advanced Hematologic Malignancies: A Systematic Review of Patient-Centered Outcomes ... cancer treatment. Any definition of “early ...