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

Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Leukemia; Multiple Myeloma; Hematologic Malignancy; Blood Cancer
• Intervention / Treatment: Behavioral: Palliative Care; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick C Johnson; Phone Number: 617-724-4000; Email: PCJOHNSON@MGH.HARVARD.EDU

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Massachusetts General Hospital Cancer Center
      • Contact: Patrick C Johnson, MD; Phone Number: 617-724-4000; Email: PCJOHNSON@MGH.HARVARD.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.; Other Names: PEACE
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.	Behavioral: Usual Care; Standard care for ACT per the treating team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Defined as at least 80% of participants reporting satisfaction with PEACE on an adapted version of the Client Satisfaction Questionnaire with scores >=20.	Up to Day 90
Quality of Life - FACT-G	Defined by Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item questionnaire that assesses cancer domains of physical well-being, social/family well-being, and emotional and functional well-being.	Baseline to day 90
Anxiety Symptoms	Assessed by the self-reported Hospital Anxiety and Depression Scale (HADS), which is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)	Baseline to day 90
Depression Symptoms	Assessed by the self-reported Hospital Anxiety and Depression Scale (HADS), which is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)	Baseline to day 90
Post-Traumatic Stress Disorder (PTSD) Symptoms	Defined by Post-Traumatic Stress Disorder Checklist (PCL), comprised of 17 items that corresponds to key symptoms of PTSD.	Baseline to day 90
Physical Symptom Burden	Defined by Edmonton Symptom Assessment (ESAS-R), which is a 10-item measure to assess symptoms relevant to patients undergoing adoptive cellular therapy	Baseline to day 90
Coping	Defined by Brief COPE which is comprised of 14 items that assesses the degree to which a participant utilizes specific coping strategies.	Baseline to day 90
Prognostic Understanding	Defined by Perception of Treatment and Prognosis (PTPQ), a survey that assesses participant understanding of illness and prognosis.	Baseline to day 90
End-of-Life Communication	Defined by PTPQ, a survey that assesses participant understanding of illness and prognosis and includes an item on patient-reported end-of-life communication.	Baseline to day 90

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Conquer Cancer Foundation
• Investigators: Principal Investigator: Patrick C Johnson, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Lymphoma; Palliative Care; Leukemia; Hematologic Malignancy; Adoptive Cellular Therapy; Palliative Care Intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms by Site; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Neoplasms; Hematologic Neoplasms; Multiple Myeloma
• Other Study ID Numbers: 22-487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No