ABSTRACT
Introduction: Clinical trials lead the progress in healthcare. To ensure reliable research conclusions, it is essential to enroll diverse patient groups. Identifying and understanding patient-reported barriers to clinical trials may help enhance recruitment among diverse patient groups.The clinical potential of proton therapy (PT) to reduce late effects is being investigated in clinical trials worldwide. Thus, for some patients, PT is only accessible by participating in clinical trials.Individuals with smoking-related head and neck cancer (HNC) are sometimes socioeconomically deprived, leading to barriers to trial participation. This study aims to identify barriers to their participation in a randomised controlled trial (RCT) involving PT. Method: Interviews were conducted with 14 HNC patients declining participation in an RCT involving PT. The interviews were transcribed and systematically analysed using an inductive approach identifying categories and themes. Results: The identified barriers to RCT-participation are: (1) existential distress, which influenced participants' mental and cognitive capacities, (2) insufficient RCT-related knowledge arising from information overload during clinical consultations, (3) the wish for safety and familiarity during the treatment trajectory, particularly for participants needing accommodation during radiotherapy, and (4) the motivation for study participation was impacted by uncertainty due to randomisation and clinical equipoise. Existential distress is identified as an overarching theme because it influences and amplifies the other three themes. Conclusion: Existential distress is a central theme that influences and amplifies other participation barriers in PT RCTs. It affects participants' comprehension of trial information, their preference for familiar environments, and their motivation to participate in clinical trials.
ABSTRACT
INTRODUCTION: On 15-16 November 2019, the Skandion Clinic in Sweden hosted the first Nordic workshop on 'Patients' perspective in proton beam therapy'. The workshop was conducted to describe and compare the patient care in PBT clinics in the Nordic countries and to initiate a collaboration, with the target to ensure patient participation and reduce the risk of inequity of access by lowering the barriers for accepting PBT in a distant clinic. The overarching aim of this workshop was to describe and compare the use of patients' perspectives in the Nordic PBT clinics. MATERIAL AND METHODS: Twelve participants attended the workshop, representing Denmark, Norway and Sweden. The participants were registered nurses working in patient care, researchers, physicist and leaders of the Skandion Clinic. RESULTS: The consensus of the workshop was that systematic use of patient experiences on individual and group level is essential for developing clinical practice and understanding the overall effects of PBT. A difference in how the Nordic countries use patient experiences in clinical practise was found. The importance of lowering the barriers for participation in national proton trials and proton treatment were emphasized, however, there is a lack of knowledge about individual and organizational barriers to accepting PBT, and further research is therefore needed. CONCLUSION: Collaboration between the Nordic countries regarding patients' perspectives in the context of PBT is of importance to compare national differences as well as to find similarities, but most importantly to learn from each other and to improve patient care. Nordic collaboration with focus on systematic collection of patient-reported outcomes in the context of PBT is unique. Collaboration in research offers the possibility to increase the inclusion of patients' perspectives in study protocols.
