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

Mass General Brigham

Status: Enrolling

Conditions: Hematologic Malignancy; Multiple Myeloma; Blood Cancer; Lymphoma; Leukemia

Treatments: Behavioral: Usual Care; Behavioral: Palliative Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05646576

22-487

Details and patient eligibility

About

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.

Full description

This is a single-center, parallel-group, randomized controlled study 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).

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Palliative Care Intervention (PEACE) Group

Experimental group

Description:

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.

Treatment:

Behavioral: Palliative Care

Usual Care Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Care