Abstract PS5-11-21: Evaluation of patient experience from participation in a randomised trial

Abstract Background: There are persistent barriers to recruitment of patients into surgical trials, especially those involving the process of randomization whereby there is uncertainty about allocation to an experimental intervention or standard treatment. A key challenge to recruitment relates to discrepant surgeon and patient preferences with lack of equipoise and a belief that outcomes for treatment options may differ in a predictable manner1. Trials involving novel methodology with limited data on efficacy compound these problems of recruitment. Minimal research has been undertaken on the process of randomization from a patient’s perspective and how this removes an element of management choice with a perceived obligation to accept the allocated treatment and not withdraw from the trial after randomization. This study aimed to explore patient experience from participation in a randomised trial evaluating fluorescent navigation with indocyanine green (ICG) for sentinel node localization in early breast cancer2. Methods: A questionnaire was issued retrospectively to all trial patients (n=100) with key themes that explored motivation for trial participation, attitudes to randomization, adequacy of information provision and concerns about standard tracer agents. Almost half (45%) of patients responded with data quantified using a 10 point Likert scale (strongly agree [1], strongly disagree [10]. A one-sample T-test determined significance of deviation from the hypothesized neutral value of six. A mixed-methods approach provided holistic assessment of patients’ experience with open-ended questions generating qualitative data for context. Employing a comprehensive post-study analysis, several positive messages were identified from this INFLUENCE trial that might inform the design and conduct of future surgical trials Results: A principle motivation for trial participation was a desire to help future patients (1.22; p<0.001). Patients appeared comfortable with random allocation to treatment groups (2.32; p<0.001) and were unconcerned about any potential negative impact from being part of the experimental arm (7.5; p<0.01). Pre-trial information was deemed accessible and comprehensive (1.93; p<0.001) and patients had sufficient time to process this before making any final decision on trial participation (1.75; p<0.001). Although patients were unconcerned about radioactive tracer usage (8.05; p<-.001), avoiding exposure to a source of radioactivity was considered an advantage of ICG alone for detection of sentinel nodes (3.67; p<0.001). Conclusion: Results of this questionnaire are reassuring and confirm that any barriers to trial participation are not primarily related to concerns about the randomization process or allocation to an experimental treatment arm. Furthermore, this data suggests that any pre-existing concerns can be mitigated through effective pre-trial engagement and communication with the research team. A strong sense of altruism prevails amongst patients and highlights the importance of emphasizing the benefits of clinical research to prospective trial participants. Optimal and well-written pre-trial information is essential and patients should be allowed adequate time to process this information and reflect upon trial participation. Well-designed consent processes will positively influence enrolment along with transparent dialogue and trust in the healthcare professionals conducting the study. 1) Ingram J, Beasant L, Benson J, et al. Pilot and Feasibility Studies 2022; 8: (46) 2) Pitsinis V, ⋯⋯⋯Benson J Ann Surg Oncol 2024; 31: 8845 - 55 Citation Format: P. M. Collins, N. Khitab, V. Pitsinis, J. Benson. Evaluation of patient experience from participation in a randomised trial [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-11-21.