What side effects are associated with this type of intervention?

Common treatments for Leukemia, such as chemotherapy, radiation therapy, targeted therapy, and stem cell transplants, often result in side effects including fatigue, nausea, vomiting, hair loss, increased risk of infections, and emotional distress. Targeted therapies may also cause specific side effects like skin rashes and diarrhea. Palliative care interventions, like those studied in the PEACE trial, aim to manage these side effects and improve the patient's overall quality of life by addressing physical, emotional, and psychosocial needs.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Leukemia, including targeted therapies like imatinib (Gleevec) for chronic myeloid leukemia (CML) and monoclonal antibodies such as rituximab (Rituxan) for certain types of leukemia. Additionally, CAR T-cell therapies like tisagenlecleucel (Kymriah) have been approved for relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). These treatments focus on targeting specific cancer cells, thereby improving survival rates and quality of life. In palliative care settings, interventions such as pain management, psychosocial support, and integrative therapies like guided imagery and relaxation techniques are also employed to enhance the overall well-being of leukemia patients.

What other types of research exist?

Promising, novel alternatives to Palliative care (PEACE) for Leukemia patients include relaxation techniques (e.g., imagery, breathing exercises), cognitive-behavioral therapy, mindfulness-based stress reduction, yoga, and music therapy. These interventions can improve mood, reduce pain, and enhance quality of life. Early palliative care interventions and addressing implementation barriers are also important considerations.

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Palliative Care for Blood Cancers (PEACE Trial)

N/A

Recruiting

Led By Patrick C Johnson, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of a hematologic malignancy

Receiving autologous adoptive cellular therapy (ACT) at MGH with an FDA approved cellular therapy product

Must not have

Already receiving palliative care (PC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 90

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on palliative care rather than direct medical treatments, side effects aren't the main concern. However, participants may experience various emotional responses to discussions about their illness and future during palliative sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a blood cancer.

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility)

Secondary study objectives

Acceptability

Anxiety Symptoms

Coping

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Palliative Care Intervention (PEACE) GroupExperimental Treatment1 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 GroupActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palliative Care

2011

N/A

~1270

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for leukemia include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, which can help reduce the number of leukemia cells in the body. Targeted therapy involves drugs that specifically target and inhibit the function of molecules involved in the growth and survival of cancer cells, thereby limiting the spread of leukemia. Immunotherapy boosts the body's immune system to recognize and destroy leukemia cells. These treatments are crucial for leukemia patients as they not only aim to control the disease but also improve quality of life by reducing symptoms and prolonging remission periods. Integrating palliative care, such as the PEACE trial, can further enhance patient experiences by addressing physical, emotional, and psychosocial needs, ultimately leading to a more holistic approach to leukemia management.

Care of the patient with hematologic malignancy: a point of view.Acute myeloid leukemia: 2021 update on risk-stratification and management.Analysis of the perceptions and attitudes to participate in radical and palliative clinical trials among Chinese lymphoma and head/neck cancer patients.