University of Birmingham

Development and feasibility testing of a digital platform to capture patient reported outcomes (PROs) for CAR-T precision cellular therapies: A multiphase, mixed-methods study (The PRO-CAR-T Study) 

Chimeric Antigen Receptor T-cell (CAR-T) therapy is a complex biological treatment for certain blood cancers, including lymphoma and acute lymphoblastic leukaemia. It uses a patient’s own T cells, reprogrammed in a lab to target and kill cancer cells. CAR-T therapy has shown long-term remission in 40 to 50 percent of patients but can cause serious side effects.

The PRO-CAR-T Study aims to develop and test a digital system that collects information directly from patients after CAR-T therapy. Patients will report symptoms and quality of life using an app on their phone, tablet, or computer. We have worked with patients, families, and clinicians to identify the most important symptoms. This information will be used to design an alert system that notifies care teams when serious symptoms are reported.

We will explore whether artificial intelligence can help identify which symptoms should trigger alerts. Using clinical data from University Hospital Birmingham and patient-reported data collected through the PRO-CAR-T system, we will analyse patterns to predict serious side effects. These linked data will be processed in the West Midlands Secure Data Environment. The goal is to improve early detection of complications and ensure timely care, especially after patients leave hospital.

The proposed research directly addresses patient needs identified in the UK Stem Cell Strategic Forum’s report "A Ten-Year Vision for Stem Cell Transplantation and Cellular Therapies", which highlights the urgent requirement for improved monitoring and support for patients undergoing advanced cellular therapies such as CAR-T. These therapies, while promising, are associated with complex side effects and significant impacts on patients’ physical and psychological wellbeing. Our patient and public involvement group, along with patient partners who have co-designed this study, have consistently emphasised the need for better tools to capture and respond to these experiences in real time. Currently, there is limited infrastructure within NHS settings to systematically collect and act on patient-reported outcomes during and after CAR-T therapy. This gap in care can lead to delayed recognition of serious symptoms and missed opportunities for timely intervention. Our research aims to fill this gap by developing a digital system that enables patients to report symptoms and quality of life remotely, ensuring their experiences are central to clinical decision-making and improving overall care delivery.

17/06/2025

SDE120

West Midlands SDE trusted research environment

Not yet published.