Patient and Public Involvement Refines the Design of ProtOeus: A Proposed Phase II Trial of Proton Beam Therapy in Oesophageal Cancer

Abstract

Neoadjuvant chemoradiotherapy (nCRT) for oesophageal cancer vastly improves overall survival but is associated with high rates of severe post-operative complications. Proton beam therapy (PBT) may reduce these toxicities by delivering a lower dose to normal tissues compared to standard radiotherapy. ProtOeus is a proposed randomised phase 2 study of nCRT in oesophageal cancer that compares PBT to standard photon radiotherapy techniques. As PBT services are often centralised in academic centres in major cities, PBT trials raise distinct challenges for researchers and patients including coordination of treatments with local centres, patient acceptance of travelling for PBT and ensuring equity of access for patients. Early patient and public involvement (PPI) in research are shown to improve the overall quality of research and increase likelihood of trial feasibility. To understand and improve trial acceptance, focus groups were held in different parts of the UK (Manchester, Cardiff and Wigan) ab initio of the trial development process to establish patient's views. Patients gave feedback on all aspects of trial design including treatment pathway and endpoint selection. The tangible impact of early PPI on the trial design is highlighted by significant trial design modifications including travel/accommodation provisions, choice of primary endpoint, randomisation ratio and fractionation schedule.

Patient and public involvement in cancer research: A scoping review

“…Out of the 66 PPI articles, 16 originated in the United Kingdom, 31–46 14 in the United States, 47–60 12 in Australia, 61–72 7 in Canada, 73–79 2 in China, 80,81 and 1 in Japan 82 . European countries included: Switzerland ( n = 2), 83,84 The Netherlands ( n = 2), 85,86 and Spain ( n = 1), 87 as well as two studies comprising several countries ( n = 2) 88,89 .…”

Beyond Participation: Evaluating the Role of Patients in Designing Oncology Clinical Trials

“…The data, as summarized in Table 1 , exhibit a range of pragmatic clinical trials conducted between 2004 and 2022, located primarily in the United States (three studies) and the United Kingdom (three studies), with one study in Denmark [ 26 , 27 , 28 , 29 , 30 , 31 , 32 ]. The trials involved patients with different cancer types, including breast (three studies), esophageal (one study), and high-grade non-muscle-invasive bladder cancer (one study); one study included multiple cancer types, namely breast, colorectal, and non-small cell lung [ 26 , 27 , 28 , 29 , 30 , 31 , 32 ].…”

“…The data, as summarized in Table 1 , exhibit a range of pragmatic clinical trials conducted between 2004 and 2022, located primarily in the United States (three studies) and the United Kingdom (three studies), with one study in Denmark [ 26 , 27 , 28 , 29 , 30 , 31 , 32 ]. The trials involved patients with different cancer types, including breast (three studies), esophageal (one study), and high-grade non-muscle-invasive bladder cancer (one study); one study included multiple cancer types, namely breast, colorectal, and non-small cell lung [ 26 , 27 , 28 , 29 , 30 , 31 , 32 ]. The patient populations in these trials consisted of individuals at different cancer stages, including early stages (two studies), advanced stages (two studies), and mixed stages (one study), as well as cases where the stage was not specified (two studies) [ 26 , 27 , 28 , 29 , 30 , 31 , 32 ].…”

“…The trials involved patients with different cancer types, including breast (three studies), esophageal (one study), and high-grade non-muscle-invasive bladder cancer (one study); one study included multiple cancer types, namely breast, colorectal, and non-small cell lung [ 26 , 27 , 28 , 29 , 30 , 31 , 32 ]. The patient populations in these trials consisted of individuals at different cancer stages, including early stages (two studies), advanced stages (two studies), and mixed stages (one study), as well as cases where the stage was not specified (two studies) [ 26 , 27 , 28 , 29 , 30 , 31 , 32 ]. The study designs employed included pragmatic clinical trials (six studies) and a pragmatic observational trial (one study).…”

Impact of patient information format on the experience of cancer patients treated with radiotherapy

“…These temporal aspects alone, raised many outstanding needs. Time becomes a worry for HCPs too, because of the patient influx and demand on resources including themselves, highlighting the importance to find a balance of addressing increasing use of technology and patient needs, alongside other resource limitations [78] .…”