PETNECK 2 - Feasibility Study and RCT, Version 1.0, 10-May-2021

• Research type

  Research Study

• Full title

  PETNECK 2: PET-CT guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head and neck cancer

• IRAS ID

  298368

• Contact name

  Paul Nankivell

• Contact email

  p.c.nankivell@bham.ac.uk

• Sponsor organisation

  University of Birmigham

• Duration of Study in the UK

  4 years, 11 months, 29 days

• Research summary

  Head and neck cancer is a disease where tumours arise in the mouth, back of the nose, throat, or voice box. It is treated by combinations of surgery, radiotherapy and chemotherapy. Currently, people who finish treatment have a clinic review every 2-6 months for 5 years to check for the cancer coming back (recurrence). Finding recurrence early increases the chance of treating it successfully. However, many patients feel they are seen too frequently, and this can increase their worry about cancer recurrence. It is also inefficient because few cancers are found this way, and clinical services are struggling with increasing demand.

  Recurrent cancers are much more likely to be found when patients ask to be seen because their symptoms have changed. Studies also show that a scan, called PET-CT, done 1-year after treatment can identify patients who are unlikely to get recurrence and could therefore be followed up less frequently.

  We have developed a new way to follow-up patients, guided by their symptoms. We propose patients have a PETCT scan 1-year after finishing treatment. If no cancer is detected, they will be educated, by a nurse/AHP, about what symptoms of recurrent cancer to look out for. The information will also be given in print and online. They will then be given an ‘open urgent appointment’ guaranteeing review by their clinical team within 2 weeks if they develop worrying symptoms, and will not have to have regular clinic visits.

  The aim of the project is to run a feasibility study followed by a clinical trial, comparing the new PET-CT guided, patient-initiated follow-up with the current routine follow-up. The aim is to find out:

  a. which is better at detecting cancer recurrence,
  b. what effects these two ways have on patients’ experience, worry about recurrence and quality-of-life,
  c. which costs less, though cost savings is not the main reason

• REC name

  Yorkshire & The Humber - South Yorkshire Research Ethics Committee

• REC reference

  21/YH/0175

• Date of REC Opinion

  1 Sep 2021

• REC opinion

  Favourable Opinion