Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
BMJ Open. 2021 Mar 19;11(3):e043929. doi: 10.1136/bmjopen-2020-043929.
Bench to bedside translation of groundbreaking treatments like chimeric antigen receptor T (CAR-T) cell therapy depends on patient participation in early phase trials. Unfortunately, many novel therapies fail to be adequately evaluated due to low recruitment rates, which slows patient access to emerging treatments. Using the Theoretical Domains Framework (TDF), we sought to identify potential patient barriers and enablers to participating in an early phase CAR-T cell therapy trial.
We used qualitative semistructured interviews to identify potential barriers and enablers to patients' hypothetical participation in an early phase CAR-T cell therapy trial. We used the TDF and directed content analysis to identify relevant domains based on frequency, relevance and the presence of conflicting beliefs.
Canadian adult patients diagnosed with haematological malignancies.
In total, we interviewed 13 participants (8 women, 5 men). Participants ranged in age from 18 to 73 (median=56) and had been living with haematological cancer from a few months to several years. We found participants were unfamiliar with CAR-T cell therapy but wished to know more about treatment safety, efficacy and trial logistics (domains: knowledge, beliefs about consequences). They were motivated by altruistic considerations, though many prioritised personal health benefits despite recognising the goals (ie, establishing safety) of early phase clinical trials (domains: goals, intentions). Every participant valued receiving medical advice from their haematologists and oncologists, though some preferred impartial medical experts to inform their decision making (domain: social influences). Finally, participants indicated that improving access to financial and social supports would improve their trial participation experience (domain: environmental context and resources).
Using the TDF allowed us to identify factors that might undermine participation to a CAR-T cell therapy trial and to optimise recruitment processes by considering patient perspectives to taking part in early phase trials. NCT03765177; Pre-results.
将突破性治疗方法（如嵌合抗原受体 T（CAR-T）细胞疗法）从实验室转化为临床实践取决于患者参与早期试验。不幸的是，由于招募率低，许多新疗法未能得到充分评估，从而减缓了患者获得新兴治疗方法的速度。本研究使用理论领域框架（TDF），旨在确定患者参与早期 CAR-T 细胞治疗试验的潜在障碍和促进因素。
我们使用定性半结构化访谈来确定患者参与早期 CAR-T 细胞治疗试验的潜在障碍和促进因素。我们使用 TDF 和定向内容分析，根据频率、相关性和存在冲突的信念，确定相关领域。
加拿大成年血液系统恶性肿瘤患者。
共访谈了 13 名参与者（8 名女性，5 名男性）。参与者年龄在 18 至 73 岁之间（中位数=56），从几个月到几年不等。我们发现，参与者对 CAR-T 细胞疗法不熟悉，但希望更多地了解治疗的安全性、有效性和试验流程（领域：知识、对后果的信念）。他们受到利他主义的激励，但许多人优先考虑个人健康益处，尽管他们认识到早期临床试验的目标（即建立安全性）（领域：目标、意图）。每位参与者都重视从血液科医生和肿瘤学家那里获得医疗建议，尽管有些人更希望由中立的医学专家来告知他们的决策（领域：社会影响）。最后，参与者表示，改善获得财务和社会支持的机会将改善他们参与试验的体验（领域：环境背景和资源）。
使用 TDF 使我们能够确定可能破坏患者参与 CAR-T 细胞治疗试验的因素，并通过考虑患者对参与早期试验的看法来优化招募流程。NCT03765177；预结果。
