Hematologic MalignancyPEACENCT05646576
Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy
A study testing Palliative Care in people with Hematologic Malignancy and Blood Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Blood Cancer, Lymphoma
- What is being tested?
- Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2022to 1 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Impaired cognition or uncontrolled mental illness that prohibits study compliance based on the oncology clinician assessment.
- Already receiving palliative care (PC).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
Patrick C Johnson, MD, 617-724-4000, PCJOHNSON@MGH.HARVARD.EDU
About this study
Official title: 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.
Read the 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.
- Conditions
- Hematologic Malignancy, Blood Cancer, Lymphoma, Leukemia, Multiple Myeloma
- Being tested
- Palliative Care, Usual Care
- Keywords
- Hematologic Malignancy, Adoptive Cellular Therapy, Palliative Care Intervention, Lymphoma, Leukemia, Multiple Myeloma, Palliative Care
- Medical subject headings
- Hematologic Neoplasms, Lymphoma, Leukemia, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareBehavioural
Also called PEACE
- 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 CareBehavioural
Standard care for ACT per the treating team.
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care Intervention (PEACE) Group | Experimental | 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. Receives: Behavioral: Palliative Care |
| Usual Care Group | Active comparator | Participants will be randomly assigned, and stratified by disease, to the Usual Care Group and will receive standard care for ACT. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (9)
Acceptability
Defined as at least 80% of participants reporting satisfaction with PEACE on an adapted version of the Client Satisfaction Questionnaire with scores >=20.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to day 90
Prognostic Understanding
Defined by Perception of Treatment and Prognosis (PTPQ), a survey that assesses participant understanding of illness and prognosis.
Measured: 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.
Measured: Baseline to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start30 Dec 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Responsible party
- Principal investigator, Patrick C. Johnson, MD, Massachusetts General Hospital
- Investigators
- Patrick C Johnson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646576
- Sponsor's protocol ID
- 22-487
- Acronym
- PEACE
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.