Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, General Campus, 501 Smyth Rd, Ottawa, ON K1H 8L6, Canada.
School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON K1G 5Z3, Canada.
Curr Oncol. 2021 May 26;28(3):2014-2028. doi: 10.3390/curroncol28030187.
Ensuring adequate, informed, and timely participation in clinical trials is a multifactorial problem. We have previously developed a systematic, tailorable survey development approach that is informed by theory, can identify barriers and enablers to participation, and can suggest recruitment strategies to address these issues. In this study, we surveyed subscribers to the Canadian Breast Cancer Network (CBCN) in order to identify a comprehensive list of theory-informed barriers and enablers relevant to participation in a hypothetical breast cancer trial.
We developed and conducted an online survey of breast cancer patients informed by the Theoretical Domains Framework and designed to determine previous experience with clinical trials, knowledge about clinical trials, and importance of a comprehensive list of barriers and enablers to trial participation. Participants were contacted by email or through social media.
From 2451 subscribers of the CBCN, we received 244 responses and 210 completed surveys (244/2451 or 9.9% participation, 210/244 or 86.1% completion). A total of 38% of respondents indicated experience in trial participation, but 83% indicated confidence in their knowledge about clinical trials. Those who had previously participated in clinical trials were more confident in their knowledge (χ= 6.77, = 0.009) and answered more knowledge questions (t = -3.90 = 0.000). Endorsed barriers and enablers to participation included 39 factors across 12 of 14 domains relevant to behaviour change. Our approach identifies barriers that might be meaningfully addressed by careful knowledge provision (''), those that may require other theory-informed approaches to address (''; ''), and those that may require tailored approaches depending on participant differences such as previous experience in trials ('').
This work demonstrates that a comprehensive, theory-guided survey of barriers and enablers to participation in breast cancer clinical trials is feasible, can lead to detailed knowledge about the issues related to participation in specific trials, and most importantly, can lead to insights about evidence-based ways to better support patient participation.
确保充分、知情和及时参与临床试验是一个多方面的问题。我们之前开发了一种系统的、可定制的调查开发方法，该方法基于理论，可以识别参与临床试验的障碍和促进因素，并可以提出解决这些问题的招募策略。在这项研究中，我们调查了加拿大乳腺癌网络（CBCN）的订阅者，以确定与参与假设性乳腺癌试验相关的全面的理论指导障碍和促进因素清单。
我们开发并进行了一项在线调查，该调查以理论领域框架为依据，旨在确定参与者之前的临床试验经验、对临床试验的了解以及全面的试验参与障碍和促进因素清单的重要性。通过电子邮件或社交媒体联系参与者。
从 2451 名 CBCN 订阅者中，我们收到了 244 份回复和 210 份完整的调查问卷（244/2451，即 9.9%的参与率，210/244，即 86.1%的完成率）。38%的受访者表示有参与试验的经验，但 83%的受访者表示对临床试验的知识有信心。那些之前参加过临床试验的人对自己的知识更有信心（χ=6.77，=0.009），并且回答了更多的知识问题（t=-3.90，=0.000）。参与的障碍和促进因素包括 12 个与行为改变相关的 14 个领域中的 39 个因素。我们的方法确定了一些障碍，这些障碍可能可以通过仔细提供知识来解决（“”），有些障碍可能需要其他基于理论的方法来解决（“”；“”），有些障碍可能需要根据参与者的差异，如之前的试验经验，采用定制的方法来解决（“”）。
这项工作表明，对乳腺癌临床试验参与的障碍和促进因素进行全面的、基于理论的调查是可行的，它可以深入了解与特定试验参与相关的问题，更重要的是，可以深入了解基于证据的方法，以更好地支持患者参与。
