ROC-oN

• Research type

  Research Study

• Full title

  ROC-oN: Radiotherapy for Oropharyngeal Cancer and impact on Neurocognition

• IRAS ID

  315880

• Contact name

  Louise Murray

• Contact email

  L.J.Murray@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Background: Oropharyngeal cancer (OPC) is a type of head and neck cancer that develops in the oropharynx (the region in and near the tonsil). Patients treated with radiotherapy for OPC receive a low dose of radiotherapy to the base of the brain. This could lead to late effects including fatigue and neurocognitive deficits (in e.g., memory, language, processing speed and attention).

  Study aim: Our overall aim is to evaluate long term fatigue and neurocognitive impairment in patients who have received radiotherapy for oropharyngeal cancer.

  Study design: Mixed-methods study.

  Study sample: Patients will be recruited from Leeds Cancer Centre and The Christie. Eligibility criteria: adult OPC patients, irradiated over the previous 10 years, ≥ 2 years after treatment, and remain disease free (n~1000).

  Study Methods:
  ROC-oN Part A: Participants will be invited by post to complete a survey consisting of several validated questionnaires regarding fatigue (Multidimensional Fatigue Inventory; MFI), patient perception of neurocognition (Medical Outcome Studies Cognitive Function Scale; MOS-Cog), HRQOL (EQ-5D-5L), mood (Profile of Mood States Short Form) and work and productivity (Work Productivity Activity Impairment; WPAI). Participants will also be invited to complete the Amsterdam Cognition Scan (ACS) online as a measure of neurocognition. A sample of participants will be asked to partake in semi-structured qualitative interviews.

  ROC-oN Part B: An exploratory analysis will be performed in patients who complete the survey and ACS to investigate associations between radiotherapy dose to base of brain structures and fatigue and neurocognitive impairment.

  Study outcomes: Findings can help with better information provision, management and/or mitigation of late effects of radiotherapy. It will help determine whether the base of the brain should be avoided when treating future head and neck cancer patients with radiotherapy and will encourage inclusion of neurocognitive function as a primary or secondary endpoint in future head and neck cancer radiotherapy trials.
  

• REC name

  West Midlands - Solihull Research Ethics Committee

• REC reference

  22/WM/0207

• Date of REC Opinion

  7 Oct 2022

• REC opinion

  Further Information Favourable Opinion