Recruiting

Palliative Care

Sponsor:

Massachusetts General Hospital

Code:

NCT05646576

Conditions

Hematologic Malignancy

Blood Cancer

Lymphoma

Leukemia

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Palliative Care

Usual Care

Study Details

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.

Conditions

Hematologic Malignancy

Blood Cancer

Lymphoma

Leukemia

Multiple Myeloma

Study ID

NCT05646576

Start date

Dec 30, 2022

Status verified date

Apr, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Impaired cognition or uncontrolled mental illness that prohibits study compliance based on the oncology clinician assessment.
  • Already receiving palliative care (PC).

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Usual Care Group

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

Interventions

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.

Primary outcome measure

  • Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility) [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Patrick C Johnson

617-724-4000PCJOHNSON@MGH.HARVARD.EDU

Locations

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Patrick C Johnson, MD

617-724-4000PCJOHNSON@MGH.HARVARD.EDU

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Hematologic Malignancy
  • Adoptive Cellular Therapy
  • Palliative Care Intervention
  • Lymphoma
  • Leukemia
  • Multiple Myeloma
  • Palliative Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-21.