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). - University Hospitals Birmingham

Safe People
Lead applicant organisation name	University of Birmingham

Safe Projects
Project title	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)
Lay summary	"CAR-T therapy, is a new immunotherapy (cancer treatment that utilizes the body's own immune system to fight cancer cells) for certain blood cancers like lymphoma and acute lymphoblastic leukaemia. It works by taking patient’s T cells (a type of white blood cell), reprogramming them in a lab to attack cancer cells, and then putting them back into the patient’s body. Results can be very effective, achieving long-term remission in 40-50% of cases. However, serious side effects are common. The PRO-CAR-T Study aims to develop and test a first-of-its-kind digital system to enhance patient safety after this treatment. This system will collect patient-reported data on symptoms following CAR-T therapy and feature an alert mechanism to notify care teams of serious symptoms for timely intervention. Researchers also want to identify if artificial intelligence (AI) can analyse symptom data from multiple patients, seeking to identify patterns and predict severe side effects or poor outcomes. This innovative approach aims to improve monitoring and treatment for CAR-T therapy patients."
Public benefit statement	The proposed research will address patient needs outlined in the UK Stem Cell Strategic Forum report and co-designed with the patient and public involvement group. It will characterize the symptoms and impacts of CAR-T therapy and the disease on patients' quality of life, focusing on the acute phase post-infusion. Findings will guide development of a digital system for remote PRO capture, in collaboration with Aparito Ltd, patients, and stakeholders. Researchers aim to create an AI model to predict adverse outcomes and assess the added value of ePRO data. This system will support symptom monitoring and improve care for CAR-T therapy patients in NHS settings.
Latest approval date	23/05/2025

Safe Data
Dataset(s) name	PATHWAY Research Data Hub: PWY030 dataset

Safe Setting
Access type	Data Licence Agreement between the collaborating organisations using secure and controlled data analysis environments.

Safe Outputs
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