Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy
PEACE
1 other identifier
interventional
90
1 country
1
Brief Summary
The goal of this study is to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT). After completion of an open pilot, participants will be randomly assigned into one of two study intervention groups. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedStudy Start
First participant enrolled
December 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 21, 2026
April 1, 2026
4 years
December 2, 2022
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility)
Defined as at least 60% of eligible participants enrolling in the study, and among those enrolled and randomized to PEACE, 80% receiving PEACE as intended.
1 day
Secondary Outcomes (9)
Acceptability
Up to Day 90
Quality of Life - FACT-G
Baseline to day 90
Anxiety Symptoms
Baseline to day 90
Depression Symptoms
Baseline to day 90
Post-Traumatic Stress Disorder (PTSD) Symptoms
Baseline to day 90
- +4 more secondary outcomes
Study Arms (2)
Palliative Care Intervention (PEACE) Group
EXPERIMENTALParticipants 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.
Usual Care Group
ACTIVE COMPARATORParticipants will be randomly assigned, and stratified by disease, to the Usual Care Group and will receive standard care for ACT.
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- Age 18 years or older.
- 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.
You may not qualify if:
- Impaired cognition or uncontrolled mental illness that prohibits study compliance based on the oncology clinician assessment.
- Already receiving palliative care (PC).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Conquer Cancer Foundationcollaborator
Study Sites (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick C Johnson, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 2, 2022
First Posted
December 12, 2022
Study Start
December 30, 2022
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.