St. Jude Care & Treatment

Menu

Close

Recruiting

CARTPLUS: Quality of Life After CAR T-Cell Therapy

About this study

CAR T-cell therapy is a type of immunotherapy that uses the patient’s own immune cells to fight cancer. This treatment works well for many people. But patients who get CAR T-cell therapy often have problems with their health and feelings for a long time after treatment. These problems can include pain, sadness, and worry about the future. Because of this, doctors want to find ways to give them extra care and support.

The CARTPLUS trial tests a new program called CAR T-Pediatrics Living with Uncertainty Series (CAR T-PLUS). The goal of this program is to help patients and families feel better during and after treatment. In the future, researchers hope to use this program to track symptoms, give advice about what to expect during treatment, and teach ways to handle stress and worry. 

Phase 1 has 2 visits. In the first visit, participants will complete surveys and share basic details about themselves. The second visit will be an interview, which will happen between 1 month and 1 year after the patient’s CAR T-cell therapy.

The surveys in Phase 1 ask questions about how the patient feels, their symptoms, and their overall health. These surveys take about 10–15 minutes and can be done on a tablet, paper, or online. After the surveys, participants will talk with a researcher about their experiences during and after treatment. The interview can be done over video or phone and will be recorded.

Phase 2 of the trial will test the improved CAR T-PLUS program to see how well it works. In this phase, patients and their caregivers will be placed into 2 groups by chance. One group will get regular care. The other group will get regular care plus the CAR T-PLUS program. People in Phase 2 will also fill out surveys and talk with a researcher about their experiences during and after treatment.

The CAR T-PLUS program will give families weekly reports about the patient’s symptoms and health. These reports will help families know what to talk about with their medical team. Families will also get 6 learning modules. These are short lessons about how to handle stress and uncertainty. The modules can be done online at home and take about 15 minutes each.

This trial is important because it may help create a program that can make life better for other patients and families in the future. 

Eligibility overview

Patient

  • 12–25 years old 
  • Treated with CAR T-cell therapy in the past year for relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)
  • Speaks and reads English or Spanish

Caregiver

  • Caregiver of a patient who is 12–25 years old and was treated with CAR T-cell therapy in the past year for relapsed or refractory B-cell ALL
  • Speaks and reads English or Spanish

Request a referral

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

CARTPLUS: Chimeric Antigen Receptor T-cell Pediatrics Living with Uncertainty (CAR T-PLUS) Intervention Proof of Concept Study

Study goal:

To improve patient and family health-related quality of life by addressing uncertainty and optimizing symptom management for patients who had CAR T-cell therapy.

Diagnosis:

Acute lymphoblastic leukemia

Age:

12–25 years old

Clinical trials categories:

Childhood Cancer Leukemia Acute Lymphoblastic Leukemia (ALL)

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

Learn more