Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy
NCT ID: NCT05646576
Last Updated: 2024-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2022-12-30
2027-04-01
Brief Summary
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The names of the study intervention groups involved in this study are:
* Palliative care (PEACE) plus usual oncology care
* Usual care (standard oncology care)
Participation in this research study is expected to last for up to 2 years.
It is expected that about 90 people will take part in this research study.
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Detailed Description
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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. Once the palliative care intervention has been refined by feedback from the pilot participants, the study will enroll 80 participants and will randomly assign the participants into one of two study intervention groups. Randomization means that a participant is put into a group by chance.
The names of the study intervention groups involved in this study are:
* Palliative care intervention (PEACE) plus usual oncology care
* Usual care (standard oncology care)
Participation in this research study is expected to last for up to 2 years.
It is expected that about 90 people will take part in this research study.
The American Society of Clinical Oncology is supporting this research study by providing funding support.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Palliative Care Intervention (PEACE) Group
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.
Palliative Care
* Palliative care (PC) intervention tailored to ACT recipients and addressing multiple PC domains with the input of ACT clinical experts, PC clinicians, and patients and caregivers.
* Domains discussed include therapeutic relationship, symptom management, prognostic awareness and illness understanding, coping with illness, treatment decision-making, EOL care.
* The palliative care intervention will be refined for the randomized control trial based on the feedback from the open pilot.
Usual Care Group
Participants will be randomly assigned, and stratified by disease, to the Usual Care Group and will receive standard care for ACT.
Usual Care
Standard care for ACT per the treating team.
Interventions
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Palliative Care
* Palliative care (PC) intervention tailored to ACT recipients and addressing multiple PC domains with the input of ACT clinical experts, PC clinicians, and patients and caregivers.
* Domains discussed include therapeutic relationship, symptom management, prognostic awareness and illness understanding, coping with illness, treatment decision-making, EOL care.
* The palliative care intervention will be refined for the randomized control trial based on the feedback from the open pilot.
Usual Care
Standard care for ACT per the treating team.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to complete surveys in English or with assistance of an interpreter.
* Diagnosis of a hematologic malignancy.
* Receiving autologous adoptive cellular therapy (ACT) at MGH with an FDA approved cellular therapy product.
Exclusion Criteria
* Already receiving palliative care (PC).
18 Years
ALL
No
Sponsors
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Conquer Cancer Foundation
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Patrick C. Johnson, MD
Principal Investigator
Principal Investigators
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Patrick C Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-487
Identifier Type: -
Identifier Source: org_study_id
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