Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palliative Care, Usual Care.
- Who it may be relevant to
- Registry conditions: Hematologic Malignancy, Blood Cancer, Lymphoma, Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study
Overview
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.
Interventions
- 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. - Behavioral Usual Care
Standard care for ACT per the treating team.
Primary outcome measures
- Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility) [Time frame: 1 day]
Secondary outcome measures (9)
- Acceptability [Time frame: Up to Day 90]
- Quality of Life - FACT-G [Time frame: Baseline to day 90]
- Anxiety Symptoms [Time frame: Baseline to day 90]
- Depression Symptoms [Time frame: Baseline to day 90]
- Post-Traumatic Stress Disorder (PTSD) Symptoms [Time frame: Baseline to day 90]
- Physical Symptom Burden [Time frame: Baseline to day 90]
- Coping [Time frame: Baseline to day 90]
- Prognostic Understanding [Time frame: Baseline to day 90]
- End-of-Life Communication [Time frame: Baseline to day 90]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Massachusetts General Hospital Cancer Center — Boston
Identifiers
NCT: NCT05646576 · 22-487