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NCT Number: NCT05646576

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

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.

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Key information

Conditions

Hematologic Malignancy Blood Cancer Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Patrick C Johnson, MD

CONTACT

[email protected]

617-724-4000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: PEACE

Usual Care

Behavioral

Standard care for ACT per the treating team.

Primary outcomes

  1. Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility)

    Time frame: 1 day

    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.

Secondary outcomes

  1. Acceptability

    Time frame: Up to Day 90

    Defined as at least 80% of participants reporting satisfaction with PEACE on an adapted version of the Client Satisfaction Questionnaire with scores >=20.

  2. Quality of Life - FACT-G

    Time frame: Baseline to day 90

    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.

  3. Anxiety Symptoms

    Time frame: Baseline to day 90

    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)

  4. Depression Symptoms

    Time frame: Baseline to day 90

    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)

  5. Post-Traumatic Stress Disorder (PTSD) Symptoms

    Time frame: Baseline to day 90

    Defined by Post-Traumatic Stress Disorder Checklist (PCL), comprised of 17 items that corresponds to key symptoms of PTSD.

  6. Physical Symptom Burden

    Time frame: Baseline to day 90

    Defined by Edmonton Symptom Assessment (ESAS-R), which is a 10-item measure to assess symptoms relevant to patients undergoing adoptive cellular therapy

  7. Coping

    Time frame: Baseline to day 90

    Defined by Brief COPE which is comprised of 14 items that assesses the degree to which a participant utilizes specific coping strategies.

  8. Prognostic Understanding

    Time frame: Baseline to day 90

    Defined by Perception of Treatment and Prognosis (PTPQ), a survey that assesses participant understanding of illness and prognosis.

  9. End-of-Life Communication

    Time frame: Baseline to day 90

    Defined by PTPQ, a survey that assesses participant understanding of illness and prognosis and includes an item on patient-reported end-of-life communication.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick C Johnson

CONTACT

[email protected]

617-724-4000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Conquer Cancer Foundation

Registry information

Official study title

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

Acronym: PEACE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2022
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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