PBT recruitment study - Exploring possible barriers to recruitment for proton beam therapy trials

Study ID: 51346
Short Title: Proton beam trials (PBT) recruitment study
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: Urology
Phase: N/A
Expected End Date: 31/08/2024
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

a) Aged at least 16 years. b) Declined participation in a partner UK clinical trial where at least one of the arms is proton beam therapy.

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It is unknown whether the results of clinical trials evaluating state-of-the-art advanced radiotherapy technologies are generalisable to the target patient population as there may be additional barriers to recruitment. In addition to the usual considerations around study participation, advanced technologies such as proton beam therapy and MR Linac therapy are only available at a small number of specialist sites meaning that travel and a stay away from home may be necessary for treatment at a distant hospital and hence participation in the study. Such factors could influence a patient’s decision to participate in such a trial and could mean that certain demographics are inadvertently excluded from the research. In order to inform future studies using advanced radiotherapy techniques such as proton beam therapy, we need to understand more about the patients that decline participation. Patients who were eligible but decline participation in a UK proton beam therapy study will be asked to complete an optional one off optional questionnaire. Patients who accept participation in a UK proton beam therapy study will be asked to (optionally) consent to sharing of basic demographic data to allow comparison of decliners and acceptors. Up to 100 patients will be recruited.

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