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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Contact Information
Primary
Patrick C Johnson
PCJOHNSON@MGH.HARVARD.EDU
617-724-4000
Time Frame
Start Date: 2022-12-30
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 90
Treatments
Experimental: Palliative Care Intervention (PEACE) Group
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.
Active_comparator: Usual Care Group
Participants will be randomly assigned, and stratified by disease, to the Usual Care Group and will receive standard care for ACT.
Related Therapeutic Areas
Sponsors
Collaborators: Conquer Cancer Foundation
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov