The PRO-CAR-T™ Study
Research type
Research Study
Full 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)
IRAS ID
320036
Contact name
Melanie J Calvert
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
3 years, 9 months, 31 days
Research summary
Chimeric Antigen Receptor T-cell (CAR-T) therapy is a new approach to cancer treatment in which the body’s own immune cells, which fight infection, are used to recognise and kill off cancer cells. CAR-T therapy is promising but the side effects of treatment can be serious. Early detection of CAR-T side effects is important so people can receive the medicines they need to help treat them. One way of monitoring the effects of treatment is by using patient-reported outcomes (or 'PROs') which involve patients filling out questionnaires to record their symptoms and feeding back the questionnaire results to their healthcare team. Collecting PROs can be done using paper questionnaires but increasingly PROs are completed electronically, using handheld devices such as a patient’s own smartphone or tablet. Digital tools to assess CAR-T patients’ symptoms are not yet widely available.
This study will develop and feasibility test a new digital system to collect patient-reported symptoms and quality of life data from CAR-T patients to facilitate clinical intervention and promote patient safety.
We will work with patients, their family members and carers, healthcare professionals, researchers, and other stakeholders to co-design the digital system. We will review the literature to identify what symptom data should be collected and map these to existing, validated questionnaires. Through meetings with interested parties, we will reach a consensus on the design of the digital system (including symptoms to be measured, questionnaire selection, timing/frequency of questionnaire completion, and alert functionality). We will test the digital system's usability before deploying it in a clinical setting to assess its feasibility. We will ask patients to complete questionnaires using the digital system before, during, and for 12 months after receiving CAR-T cell therapy. A qualitative sub-study (interviews) will explore patients’ and healthcare professionals’ experiences of using the digital system.
REC name
HSC REC B
REC reference
23/NI/0104
Date of REC Opinion
28 Sep 2023
REC opinion
Further Information Favourable Opinion