Title: Improving quality of life through the routine use of the Patient Concerns Inventory for head and neck cancer patients (PCI-QOL)
Funder: Department of Health and Social Care

Abstract: The problem The consequences of treatment from Head and Neck cancer (HNC) patients have profound detrimental impact on impaired QOL, emotional distress, delayed recovery and frequent use of healthcare. Deleterious effects on basic functions such as speech, swallowing and appearance can have lasting negative influence on emotional well-being and social integration. Patients tend not to raise issues of concern in their clinical interactions, which can impact negatively on how issues are dealt with and on outcome. The pilot data Patient groups have maintained involvement with the PCI from its inception, and have provided patient feedback in pilot work in the Merseyside and Cheshire region. Pilot data suggests that using the PCI in clinic is feasible, appreciated by patients and allows emotional issues to be discussed - notably fears of recurrence, anxiety, depression. The pilot data although encouraging does not provide level 1 evidence. Aims To determine if the routine use of the PCI in review clinics during the first year following treatment can improve overall quality of life, reduce the social-emotional impact of cancer and reduce significant levels of distress. Furthermore, we aim to describe the economic costs and benefits of using the PCI. Primary and Secondary outcomes The primary outcome is the percentage of participants with less than good overall quality of life at the final one-year clinic as measured by the single UWQOLv4 question. Secondary outcomes at one-year are the mean social-emotional subscale (UWQOLv4) score, Distress Thermometer (DT) score &ge;4, and key health economic measures (QALY-EQ-5D-3L; CSRI). Methods All HNC patients treated with curative intent are included. Patients treated palliatively, with a history of previous HNC, recurrence, cognitive impairment, psychoses or dementia are excluded. This will be a pragmatic cluster randomised control trial with consultants randomised to either using or not using the PCI at clinic. It will involve two sites: Leeds and Liverpool. Both have some experience in the PCI. 416 patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome. Before treatment, eligible patients will be asked to consent to participation in the 'research cohort'. Patients agree to their clinical data being used in the trial and to completing research questionnaires before each post-treatment consultation, some of which might be used in their consultation. Completion of all pre-consultation questionnaires and PCI will be by computer (desktop, tablet, IPAD). Quality Assurance is by initial training and booster sessions for consultants and a post consultation telephone survey with patient participants. A Steering Group, set up in advance, will guide the research and a joint-site Management group will manage it. Each site will have a Project Team meeting regularly to review progress. Day to day management issues will be addressed with each unit Lead Researcher. A data manager (based at Aintree R&D) will have overall responsibility for ensuring data quality and integrity. The study will last three years, 5 months for staff training and a technical set-up and pilot of the IT structure, 12 months recruitment, 15 months for follow-up and 4 months for analysis, write-up and initial dissemination. Analysis will be by intention to treat, the two patient groups being compared after adjusting for relevant case-mix and for effects of patients being within consultant clusters. Dissemination plan Findings of this study will be disseminated through patient forums, health partners, academic health sciences networks, commissioners and healthcare providers, national Associations, appropriate groups within the Department of Health, and international organisations. Adoption widely across HNC centres in the UK will involve national training days and locality specific support. Funding will be sought for wider rollout through speciality associations and other agencies.

Lay abstract: 'What is the problem' Following treatment for head and neck cancer, patients can have impaired quality of life, emotional distress, delayed recovery and more frequent use of healthcare. Common problems include chewing/eating, dental, appearance/social, speech and fear of recurrence. There is a reluctance for patients to raise their concerns within a busy clinic setting and a general failure to address the wider issues of support they require. The Patient Concerns Inventory (PCI) has been developed as a tool to help overcome these difficulties and improve patient experience and outcome. The PCI has 56 items which patients select from to help guide their outpatient consultation. It helps to direct the consultation and can trigger onward referral for patient concerns. 'Why this is important' The PCI supports several national initiatives about how to bring about more person-centred care. The National Cancer Survivorship Initiative places patients at the heart of cancer care with their individual needs identified and met. Research so far on using the PCI with head and neck cancer patients strongly suggests that it has a positive impact on outcome. However, its use has largely been confined to a single clinic setting with no formal evaluation of its regular routine use over time and in particular its impact on quality of life during the first year following treatment when most benefit is expected. We expect the PCI to work by improving the 'conversations' between patient and clinician. 'How the study will be conducted' - 'Main outcomes' This will be a randomised trial, with consultants randomised to using or not using the PCI throughout their trial participation. The main outcome after one year follow-up is the percentage of patients with less than good overall quality of life.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CANCER AND NEOPLASMS