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National Institute for Health Research Biomedical Research Centre

Patient and public focus groups support design of UK’s first multi-centre proton therapy trial

TORPEdO (TOxicity Reduction using Proton bEam therapy for Oropharyngeal cancer) is the first proposed multi-centre phase III proton therapy trial in the UK

It aims to assess the benefit of proton therapy in terms of patient-reported toxicities, quality-of-life and cost-effectiveness.

The trial targets a patient population who are not currently eligible for proton therapy on the NHS. The trial will be the first in the UK involving protons and aims to generate the evidence for benefit in patients with a type of head and neck cancer presenting at a younger age and where 5-year survival rates are high.

Survivorship issues are important in patients with a good prognosis – long-term toxicities impact on health-related quality-of-life and have health economic consequences. As it can decrease radiation exposure in healthy tissues, proton therapy should benefit patients by reducing toxicity and the long-term consequences of treatment. The trial will establish and test the logistics of carrying out trials where patients must travel to receive radiotherapy.

With patient demand to participate in the trial likely to be high, but with complex needs, BRC researchers, PPI staff and collaborators from Leeds and Sheffield worked together to involve patient and carer insight in the study design, exploring emotional and practical issues from the patients’ perspective.

Three focus groups held in Manchester, Leeds and Sheffield were attended by 33 patients who had been treated with standard radiotherapy for head and neck cancer within a year and 8 carers. Through researcher explanation and facilitated discussion the contributors explored the following themes:

  • Patients’ views about the proposed TORPEdO trial
  • Acceptability of randomisation
  • Patient pathway when enrolled in the trial
  • Willingness to travel to either Manchester or London
  • Trial design and end points

Outcome

  • An enthusiasm to participate in TORPEdO, with 50% chance of receiving proton treatment not dissuading participation in the trial as it would be helping future patients;
  • Advice to minimise the time intervals between stages of the patient pathway;
  • Advice to ensure comprehensive information about the centres is provided to participants;
  • A willingness to travel from Leeds/ Sheffield to the Manchester centre. Many contributors preferred option was apartment-based accommodation allowing friends/ family to stay with them during treatment to provide emotional and social support;
  • 93% of contributors felt that the first six physical questions on the proposed outcome measures questionnaire were good primary measures, with the most common suggested missing symptom being hearing loss, as well as fatigue and bone damage.

Impact / potential impact

  • Feedback on the acceptability and logistics of the trial design will help to ensure that recruitment is successful.
  • An editorial publication in Clinical Oncology authored by researchers, PPI staff and a patient contributor
  • NIHR Biomedical Research Centre at The Royal Marsden and The Institute of Cancer Research plan to replicate methodology for Proton Beam Therapy research in London and surrounding areas
  • Development of PPI skills for researchers who now plan to incorporate patient insight as standard going forward.