Protocol for a mixed-methods study to develop and feasibility test a digital system for the capture of patient-reported outcomes (PROs) in patients receiving chimeric antigen receptor T-cell (CAR-T) therapies (the PRO-CAR-T study).
Author
Hughes, Sarah EMcMullan, Christel
Aiyegbusi, Olalekan Lee
Shaw, Karen
Kinsella, Francesca
Ferguson, Paul
Khatsuria, Foram
Burns, David
Pyatt, Lester
Ansell, John
Chakera, Evelyn
Richardson-Abraham, Julie
Denniston, Alastair K
Davies, Elin Haf
Craddock, Charles
Calvert, Melanie
Publication date
2024-03-29
Metadata
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Abstract Introduction: Chimeric antigen receptor (CAR) T-cell therapies are novel, potentially curative therapies for haematological malignancies. CAR T-cell therapies are associated with severe toxicities, meaning patients require monitoring during acute and postacute treatment phases. Electronic patient-reported outcomes (ePROs), self-reports of health status provided via online questionnaires, can complement clinician observation with potential to improve patient outcomes. This study will develop and evaluate feasibility of a new ePRO system for CAR-T patients in routine care. Methods and analysis: Multiphase, mixed-methods study involving multiple stakeholder groups (patients, family members, carers, clinicians, academics/researchers and policy-makers). The intervention development phase comprises a Delphi study to select PRO measures for the digital system, a codesign workshop and consensus meetings to establish thresholds for notifications to the clinical team if a patient reports severe symptoms or side effects. Usability testing will evaluate how users interact with the digital system and, lastly, we will evaluate ePRO system feasibility with 30 CAR-T patients (adults aged 18+ years) when used in addition to usual care. Feasibility study participants will use the ePRO system to submit self-reports of symptoms, treatment tolerability and quality of life at specific time points. The CAR-T clinical team will respond to system notifications triggered by patients' submitted responses with actions in line with standard clinical practice. Feasibility measures will be collected at prespecified time points following CAR T-cell infusion. A qualitative substudy involving patients and clinical team members will explore acceptability of the ePRO system. Ethics and dissemination: Favourable ethical opinion was granted by the Health and Social Care Research Ethics Committee B(HSC REC B) (ref: 23/NI/0104) on 28 September 2023. Findings will be submitted for publication in high-quality, peer-reviewed journals. Summaries of results, codeveloped with the Blood and Transplant Research Unit Patient and Public Involvement and Engagement group, will be disseminated to all interested groups. Trial registration number: ISCTRN11232653. Keywords: Gene therapy; HAEMATOLOGY; Patient Reported Outcome Measures; Patient-Centered Care; Quality of Life; eHealth.Citation
Hughes SE, McMullan C, Aiyegbusi OL, Shaw K, Kinsella F, Ferguson P, Khatsuria F, Burns D, Pyatt L, Ansell J, Chakera E, Richardson-Abraham J, Denniston AK, Davies EH, Craddock C, Calvert M. Protocol for a mixed-methods study to develop and feasibility test a digital system for the capture of patient-reported outcomes (PROs) in patients receiving chimeric antigen receptor T-cell (CAR-T) therapies (the PRO-CAR-T study). BMJ Open. 2024 Mar 29;14(3):e085392. doi: 10.1136/bmjopen-2024-085392. PMID: 38553074; PMCID: PMC10982800.Type
ArticlePMID
38553074Journal
BMJ OpenPublisher
BMJ Publishing Groupae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2024-085392