RecruitingRecruiting
Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy
NCT05646576 · Massachusetts General Hospital
In plain English
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Official title
Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study
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.
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).
Study design
Enrollment target: 90 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-12-30
Estimated completion: 2027-04-01
Last updated: 2026-04-21
Interventions
Behavioral: Palliative CareBehavioral: Usual Care
Primary outcomes
- • Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility) (1 day)
Sponsor
Massachusetts General Hospital · other
With: Conquer Cancer Foundation
Contacts & investigators
ContactPatrick C Johnson · contact · PCJOHNSON@MGH.HARVARD.EDU · 617-724-4000
InvestigatorPatrick C Johnson, MD · principal_investigator, Massachusetts General Hospital
All locations (1)
Massachusetts General Hospital Cancer CenterRecruiting
Boston, Massachusetts, United States