A mixed-methods study of the physical and psycho-cognitive effects of Chimeric Antigen Receptor T-cell (CAR-T) therapy, in UK adults and their caregivers, over time.

Research Question What impact does CAR-T (Chimeric Antigen Receptor T-cell) therapy have on UK patients and caregivers? Background CAR-T is a major new therapy, increasingly used for some relapsed/refractory blood cancers. It can, however, be extremely toxic, causing psycho-cognitive, emotional, and physical difficulties. To address these issues, the NHS Long Term Plan (LTP) suggests cancer patients have individual needs assessments, personalised care plans, and health and wellbeing information and support; it also advocates recognition and support for unpaid carers. Unfortunately, much of the evidence to underpin such activities originates from the USA, and is limited to the first 18 months, although difficulties may persist longer. Lack of follow-up data within the NHS means that patients and caregivers may have unmet needs that are unknown to clinicians, Government and Charity stakeholders; as verified by the PPI activities that have underpinned this proposal. Aim To generate evidence about the impact of CAR-T therapy on UK adults with blood cancer, and their caregivers; and identify unmet needs. Objectives Explore patient/caregiver experiences of CAR-T, via in-depth interviews Assess physical and mental health via a clinic-based survey Synthesize findings, identify unmet need, and consider methods of addressing these Methods This work is set within the Haematological Malignancy Research Network (HMRN), a UK population-based patient cohort that includes all blood cancer subtypes. Established in 2004, HMRN s catchment population (~4 million people) is broadly representative of the UK and contains 14 hospitals, including the region s CAR-T centre. HMRN has no exclusions by age, sex, ethnicity, or any other factor. All patients have clinical data collected from their medical records, and all are linked to national data on deaths, cancers and hospital episodes. This mixed-methods study will involve: 1) Distribution of a self-completed questionnaire to all HMRN patients who have received CAR-T, at each clinic visit, combining validated measures of quality of life, and physical and psycho-cognitive effects; with linkage to HMRN s core data, and analysis using standard methods; 2) Qualitative in-depth interviews with ~30 patient/caregiver dyads, purposively sampled within a framework used to monitor participant characteristics, followed by thematic data analysis; and 3) Data synthesis to explore similarities and differences between interview and survey findings. Study packs will be prepared for participants, who will be identified in clinic/via HMRN. Timelines for Delivery An 18-month project will be delivered, beginning November 2024. Months 1-3: PPI and Study Management Teams will be established, study approvals acquired and initiation meetings held at SJUH; Months 2-18: Survey data collection and potential interviewees identified, followed by fieldwork/analysis; Months 16-18: Data analysis (survey) and Synthesis to compare findings. Anticipated Impact and Dissemination CAR-T care/support will become increasingly evidence-based and promote health and wellbeing, thereby mitigating against poorer outcomes. Outputs will be tailored to specific stakeholders. Patients, families, the public and charities will be informed via our lay-website, social-media site, Newsletters, Open Days and Support Groups; and at patient conferences. Researchers/clinicians will be informed via peer-reviewed articles, our study website, and at conferences. The clinical applicants are well-placed to disseminate findings within the NHS.