Faculty of Health and Life Sciences, De Montfort University, Leicester, UK.
University Hospitals of Leicester NHS Trust, Infirmary Square, Leicester, LE1 5WW, UK.
Trials. 2023 Nov 25;24(1):754. doi: 10.1186/s13063-023-07572-x.
Window-of-opportunity trials (WOT) are a study design that have been used to investigate drug activity in endometrial cancer (EC). Recruitment to cancer clinical trials by patients from ethnic minority groups is reported to be lower than for patients of White ethnicity.
A verbal questionnaire was conducted with White and Asian/Asian British ethnicity patients who had undergone treatment for EC. Strategic purposeful sampling was used to recruit patients from diverse social/educational backgrounds. Questions explored: background knowledge of clinical research, WOT study design, and views on medications that might be investigated. Thematic analysis was used to explore motivations for WOT participation and perceived barriers.
In total, 21 patients were recruited to the study (15 White and 6 Asian/Asian British). Views on optimum time to receive trial information differed, preferences ranging from 'at the time of diagnosis' to 'a few days after diagnosis'. The choice of medication under investigation had a strong influence on potential willingness to participate, with greater interest reported in medications derived from vitamins or food supplements rather than hormone-based drugs. Potential barriers to participation included concern over potential side-effects and the emotional/physical burden of a cancer diagnosis prior to major surgery.
This study provides important insights into patients' views on WOT participation in EC and raises issues that need to be considered for future trial design and participant recruitment materials. The timing and format of study information and type of substance under investigation were factors influencing potential participation. Future studies should consider using multi-lingual visual information videos to address information needs, as this may encourage participation by ethnic minority patients.
机会窗试验(WOT)是一种已被用于研究子宫内膜癌(EC)药物活性的研究设计。据报道,少数民族患者参与癌症临床试验的比例低于白人患者。
对接受 EC 治疗的白人患者和亚裔/亚裔英国患者进行了口头问卷调查。采用战略有目的抽样方法招募来自不同社会/教育背景的患者。问题探讨了:对临床研究的背景知识、WOT 研究设计以及对可能被调查药物的看法。使用主题分析来探讨参与 WOT 的动机和感知障碍。
共有 21 名患者入组本研究(15 名白人,6 名亚裔/亚裔英国)。对接受试验信息的最佳时间的看法存在差异,偏好范围从“诊断时”到“诊断后几天”。正在调查的药物选择对潜在参与意愿有很大影响,对源自维生素或食物补充剂而不是激素药物的药物更感兴趣。潜在的参与障碍包括对潜在副作用的担忧,以及在接受主要手术之前癌症诊断带来的情绪/身体负担。
本研究提供了关于 EC 患者对 WOT 参与的重要见解,并提出了未来试验设计和参与者招募材料需要考虑的问题。研究信息的时间和格式以及正在调查的物质类型是影响潜在参与的因素。未来的研究应考虑使用多语言视觉信息视频来满足信息需求,因为这可能会鼓励少数民族患者参与。