Evaluation of patient experience from participation in the randomized INFLUENCE trial on fluorescence-guided sentinel node surgery

TY - JOUR

T1 - Evaluation of patient experience from participation in the randomized INFLUENCE trial on fluorescence-guided sentinel node surgery

AU - Collins, Phoebe

AU - Pitsinis, Vasileios

AU - Khitab, Nadia

AU - Benson, John R

N1 - Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved.

PY - 2026/5/26

Y1 - 2026/5/26

N2 - BACKGROUND: Recruitment to surgical trials is limited by strong patient and surgeon preferences, lack of equipoise, and anxiety surrounding randomization. There is minimal research exploring patient perspectives on randomization within surgical oncology, especially involving novel technologies like fluorescence-guided surgery. This study assessed patient experience following participation in the INFLUENCE trial, which compared indocyanine green fluorescence with standard tracer methods for sentinel lymph node localization in early breast cancer.METHODS: A retrospective questionnaire, distributed to 100 patients, examined motivation for trial participation, attitudes toward randomization, adequacy of written and verbal information, and concerns about radioactive or blue-dye tracers. Quantified responses, using a 10-point Likert scale, were analyzed using 1-sample t tests against a neutral value of 6 as the rounded midpoint. Free-text comments were analyzed thematically.RESULTS: The response rate was 45%. Altruism emerged as the motivator for participation (mean, 1.22; standard deviation, 0.85; P < .001). Patients experienced comfort with the process of randomization (mean, 2.32; P < .001; standard deviation, 2.228) and low concern about assignment to the experimental arm (mean, 7.5; standard deviation, 2.865; P < .01). Pretrial information was deemed comprehensive and accessible (mean, 1.93; standard deviation, 1.717; P < .001), with sufficient time for decision-making (mean, 1.75; standard deviation, 1.465; P < .001). Although patients expressed low levels of anxiety about use of radioactive tracers (mean, 8.05; standard deviation, 2.59; P < .001), avoidance of radioactivity was considered an advantage of indocyanine green (mean, 3.67; standard deviation, 2.59; P < .001).CONCLUSION: Randomization and experimental intervention allocation may not constitute major barriers to surgical trial recruitment. Clear information and adequate time for decision-making enhance acceptability. Altruistic motivations may support recruitment into a range of future surgical studies.

AB - BACKGROUND: Recruitment to surgical trials is limited by strong patient and surgeon preferences, lack of equipoise, and anxiety surrounding randomization. There is minimal research exploring patient perspectives on randomization within surgical oncology, especially involving novel technologies like fluorescence-guided surgery. This study assessed patient experience following participation in the INFLUENCE trial, which compared indocyanine green fluorescence with standard tracer methods for sentinel lymph node localization in early breast cancer.METHODS: A retrospective questionnaire, distributed to 100 patients, examined motivation for trial participation, attitudes toward randomization, adequacy of written and verbal information, and concerns about radioactive or blue-dye tracers. Quantified responses, using a 10-point Likert scale, were analyzed using 1-sample t tests against a neutral value of 6 as the rounded midpoint. Free-text comments were analyzed thematically.RESULTS: The response rate was 45%. Altruism emerged as the motivator for participation (mean, 1.22; standard deviation, 0.85; P < .001). Patients experienced comfort with the process of randomization (mean, 2.32; P < .001; standard deviation, 2.228) and low concern about assignment to the experimental arm (mean, 7.5; standard deviation, 2.865; P < .01). Pretrial information was deemed comprehensive and accessible (mean, 1.93; standard deviation, 1.717; P < .001), with sufficient time for decision-making (mean, 1.75; standard deviation, 1.465; P < .001). Although patients expressed low levels of anxiety about use of radioactive tracers (mean, 8.05; standard deviation, 2.59; P < .001), avoidance of radioactivity was considered an advantage of indocyanine green (mean, 3.67; standard deviation, 2.59; P < .001).CONCLUSION: Randomization and experimental intervention allocation may not constitute major barriers to surgical trial recruitment. Clear information and adequate time for decision-making enhance acceptability. Altruistic motivations may support recruitment into a range of future surgical studies.

U2 - 10.1016/j.surg.2026.110289

DO - 10.1016/j.surg.2026.110289

M3 - Article

C2 - 42190367

SN - 0039-6060

VL - 196

SP - 110289

JO - Surgery

JF - Surgery

ER -