Clinical trial NCT05646576: Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy
Official title: Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Blood Cancer
Lymphoma
Leukemia
Multiple Myeloma
Keywords: Hematologic Malignancy
Adoptive Cellular Therapy
Palliative Care Intervention
Lymphoma
Leukemia
Multiple Myeloma
Palliative Care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
First posted: 2022-12-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility)
timeFrame: 1 day
Secondary outcomes:
measure: Acceptability
timeFrame: Up to Day 90
measure: Quality of Life - FACT-G
timeFrame: Baseline to day 90
measure: Anxiety Symptoms
timeFrame: Baseline to day 90
measure: Depression Symptoms
timeFrame: Baseline to day 90
measure: Post-Traumatic Stress Disorder (PTSD) Symptoms
timeFrame: Baseline to day 90
measure: Physical Symptom Burden
timeFrame: Baseline to day 90
measure: Coping
timeFrame: Baseline to day 90
measure: Prognostic Understanding
timeFrame: Baseline to day 90
measure: End-of-Life Communication
timeFrame: Baseline to day 90
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Patrick C Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: