Palliative Care for Blood Cancers
(PEACE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Disqualifiers: Impaired cognition, Uncontrolled mental illness, others
No Placebo Group
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.
12345Is 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.
12678How 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.
12489Eligibility 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
+1 more
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
Trial 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
Participant Groups
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.
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.
Palliative Care is already approved in European Union, United States, Canada, Australia 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
🇦🇺 Approved in Australia as Palliative Care for:
- Symptom management for various conditions including cancer, neurological disorders, and end-of-life care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General Hospital Cancer CenterBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
Conquer Cancer FoundationCollaborator
References
Palliative care of patients with haematological malignancies: strategies to overcome difficulties via integrated care. [2022]Palliative care, hospice care, and end of life care have been the focus of increased attention over the past two decades; palliative care has shifted from being introduced only at the end of life to becoming an integrated part of routine care for patients. Currently, the timing and extent of the integration of palliative care into standard medical care practice depends on the underlying disease. Patients with haematological malignancies receive less palliative care initiated at a later disease stage compared with patients with other types of cancer. All patients in need of palliative care, hospice care, and end of life care should be given the chance to benefit from these types of care. Patients, their relatives, health-care professionals, and the health-care system can all benefit from the closer integration of palliative, hospice, and end of life care, even in combination with disease orientated treatment. Important factors to consider when introducing palliative care for patients with haematological malignancies are the different treatment strategies for each disease, the heterogeneous dynamics of the different haematological malignancies, the broad variance of therapeutic effects, and patients' dependence on the health-care system for the administration of transfusions and antimicrobial treatment, which is different from patients with solid tumours. Key areas that physicians should pay particular attention to are strategies for communication with patients to aid their understanding of their illness and prognosis and concepts to address special needs of patients with haematological malignancies (eg, transfusion requirements and symptom control). Because haematological malignancies mainly affect patients in advanced age, this Series paper integrates a special focus on age-associated topics.
Palliative care for patients with hematologic malignancies: are we meeting patients' needs early enough? [2022]Palliative care for patients with cancer, and more recently for patients with hematologic malignancies, has increasingly been shown to be beneficial, with mounting evidence pointing to its vast benefits both to patients and caregivers. Despite this, there is a significant gap in integration of palliative care into usual cancer care for patients with hematologic malignancies.
Palliative care and the hemato-oncological patient: can we live together? A review of the literature. [2015]Current evidence suggests that patients with hematological malignancies less frequently access palliative care services, and for those who do, this tends to occur later in their illness than their counterparts with solid malignancies. These patients are also more likely to die in hospital following escalating interventions. This approach to care that considers palliative care referral after most treatments are exhausted has implications for the quality of palliative care intervention possible. An episodic approach engaging palliative care according to needs rather than prognosis may be more valuable. The successful integration of palliative care into the care of hemato-oncological patients requires recognition by palliative care physicians of the particular issues encountered in care, namely, the difficulty in individual prognostication; ongoing therapeutic goals of curability or long term survival; the technical nature and complications of treatment; the speed of change to a terminal event; the need for pathology testing and transfusion of blood products as death approaches; the potentially reversible nature of intercurrent events such as infection; and the long relationships that develop between patients and their hematologists. Meanwhile, hematologists should be aware of the benefits of palliative care earlier in an illness trajectory and that palliative care does not equate to terminal care only. This review summarizes current practices and barriers to referral, and suggests recommendations for collaborative care and further research in the palliation of hemato-oncological patients. In doing so, it highlights to palliative care and hematology physicians how successful integration of their disciplines may improve their care of these patients.
Advancing Palliative Care Integration in Hematology: Building Upon Existing Evidence. [2023]Patients with hematologic malignancies and their families are among the most distressed of all those with cancer. Despite high palliative care-related needs, the integration of palliative care in hematology is underdeveloped. The evidence is clear that the way forward includes standard-of-care PC integration into routine hematologic malignancy care to improve patient and caregiver outcomes. As the PC needs for patients with blood cancer vary significantly by disease, a disease-specific PC integration strategy is needed, allowing for serious illness care interventions to be individualized to the specific needs of each patient and situation.
Early palliative care in haematological patients: a systematic literature review. [2021]Early palliative care together with standard haematological care for advanced patients is needed worldwide. Little is known about its effect. The aim of the review is to synthesise the evidence on the impact of early palliative care on haematologic cancer patients' quality of life and resource use.
The symptom burden of patients with hematological malignancy: a cross-sectional observational study. [2022]Current literature suggests that contact with specialist palliative care for patients diagnosed with hematological malignancy is infrequent. As part of an investigation into patterns of care, the symptom profile of this patient group required elucidation.
Specific challenges in end-of-life care for patients with hematological malignancies. [2020]The disease-related burden of patients with hematological malignancies is comparable with patients suffering from solid tumors. Palliative care offers relief from suffering independent of type of disease and prognosis. The prevalence of hematological malignancies is expected to increase in the next 20 years because of better therapeutic options with longer survival and because of the aging population. However, patients with hematological malignancies are underrepresented in palliative care as these diseases are associated with special care needs and prognostic uncertainty, which differ from the unambiguity of terminally ill patients with solid tumors. This review describes the recent studies and guidelines addressing the problems in palliative care for patients with hematological malignancies.
Palliative and End-of-Life Care for Patients With Hematologic Malignancies. [2023]Hematologic malignancies are a heterogeneous group of diseases with unique illness trajectories, treatment paradigms, and potential for curability, which affect patients' palliative and end-of-life care needs. Patients with hematologic malignancies endure immense physical and psychological symptoms because of both their illness and often intensive treatments that result in significant toxicities and adverse effects. Compared with patients with solid tumors, those with hematologic malignancies also experience high rates of hospitalizations, intensive care unit admissions, and in-hospital deaths and low rates of referral to hospice as well as shorter hospice length of stay. In addition, patients with hematologic malignancies harbor substantial misperceptions about treatment risks and benefits and frequently overestimate their prognosis. Even survivors of hematologic malignancies struggle with late effects, post-treatment complications, and post-traumatic stress symptoms that can significantly diminish their quality of life. Despite these substantial unmet needs, specialty palliative care services are infrequently consulted for the care of patients with hematologic malignancies. Several illness-specific, cultural, and system-based barriers to palliative care integration and optimal end-of-life care exist in this population. However, recent evidence has demonstrated the feasibility, acceptability, and efficacy of integrating palliative care to improve the quality of life and care of patients with hematologic malignancies and their caregivers. More research is needed to develop and test population-specific palliative and supportive care interventions to ensure generalizability and to define a sustainable clinical delivery model. Future work also should focus on identifying moderators and mediators of the effect of integrated palliative care models on patient-reported outcomes and on developing less resource-intensive integrated care models to address the diverse needs of this population.
Haematology and palliative medicine: moving forward. [2015]The documentation of details on the provision of medical care for haematology patients in the palliative care setting not only provides useful baseline information for clinical consideration and debate, but signals that the scholarship in this area has come of age. Previously the research literature predominantly centred on the question of whether palliative medicine could or should be integrated into the care of haematology patients. The assumption is now in the affirmative and the concern becomes how best to effectively achieve this end.