RfPB Clinical Trial

'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 an item prompt list to help overcome these difficulties and improve patient experience and outcome. Pilot work has shown that it can be integrated in to routine care with huge potential benefit and little cost implication or burden. 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.

Primary outcome:

  1. The primary outcome measure is overall Quality of Life, specifically the percentage with less than good overall QOL at the final one-year clinic as measured by the single UWQOL-v4 question.

Secondary outcomes:

  1. Mean social-emotional subscale score of UW-QOL. The social-emotional subscale (28) is the mean of 6 domain scores (each 0-100) - anxiety, mood, pain, activity, recreation and shoulder function.
  2. Distress Thermometer (DT) score of 4 or more (range 0 to 10).
  3. Quality-adjusted life year (QALY) as a summary measure of health benefit for economic evaluation, using the EQ-5D-5L
  4. Health service use and costs using a Client Service Receipt Inventory (CSRI).

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