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NCT05646576 | RECRUITING | Hematologic Malignancy


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

Massachusetts General Hospital

Information provided by (Responsible Party):

Patrick C. Johnson, MD

Brief 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). 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.

Condition or disease

Hematologic Malignancy

Blood Cancer

Lymphoma

Leukemia

Multiple Myeloma

Intervention/treatment

Palliative Care

Usual Care

Phase

NA

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
Estimated Enrollment : 90 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study
Actual Study Start Date : 2022-12-30
Estimated Primary Completion Date : 2026-12-30
Estimated Study Completion Date : 2027-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).

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

Location Details

NCT05646576


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Locations


RECRUITING

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02215

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