Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05646576
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palliative Care — BEHAVIORAL
    * 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 — BEHAVIORAL
    Standard care for ACT per the treating team.

Study Details

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.

Key Dates

Start date
Dec 30, 2022
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02215
Patrick C Johnson, MD
[email protected]
617-724-4000

Find similar trials in Boston, MA

By condition
Leukemia (other)Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Massachusetts General Hospital Cancer Center· Boston, MA

Related Studies