NCT05646576

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-30
• Primary completion: 2026-12-30
• Completion: 2027-04-01
• First posted: 2022-12-12
• Last updated: 2024-05-29

Locations

1 site across 1 country: United States