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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

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 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

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

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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,000 Previous Clinical Trials
13,309,409 Total Patients Enrolled
47 Trials studying Leukemia
4,767 Patients Enrolled for Leukemia
Conquer Cancer FoundationOTHER
19 Previous Clinical Trials
3,835 Total Patients Enrolled
Patrick C Johnson, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Palliative Care Clinical Trial Eligibility Overview. Trial Name: NCT05646576 — N/A
Leukemia Research Study Groups: Palliative Care Intervention (PEACE) Group, Usual Care Group
Leukemia Clinical Trial 2023: Palliative Care Highlights & Side Effects. Trial Name: NCT05646576 — N/A
Palliative Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05646576 — N/A
~49 spots leftby Dec 2026