Information for Researchers

GRRAND-F is a feasibility trial that is looking to see if a rehabilitation treatment programme is acceptable for patients who have been discharged from hospital after neck dissection surgery for Head and Neck Cancer (HNC). Participants will be randomised to receive either standard NHS care or the GRRAND-F intervention programme. This programme has been designed by physiotherapists and HNC patients.  It is hoped that this small study will help us to plan a larger study that will aim to investigate better physiotherapy treatments for people who had had this surgery.

BACKGROUND

Head and neck cancer is becoming more common in the UK. The main treatments for HNC include surgery, radiotherapy, and chemotherapy. Treatment outcomes for HNC are improving, however, surgical side-effects can be significant, including swallowing problems, fatigue, anxiety, and shoulder problems. About half of people cannot return to work following their surgery and we do not know what the best way is to help people best recover. 

STUDY DESIGN

This is a multicentre randomised control trial and we are hoping to recruit 60 men and women who have neck dissection surgery for HNC in up to 4 UK based centres.   

INTERVENTIONS

Participants will be randomised to have treatment consisting of either:

(a) Usual Care – inpatient rehabilitation programme

(b) Usual Care as above PLUS an individualised rehabilitation programme over up to six sessions

Data will be collected on the physiotherapy interventions received and participants will be asked to complete questionnaires at six (and 12 months) after randomisation.

ELIGIBILITY CRITERIA

Inclusion Criteria

We will include those:

  • Aged 18 years and above
  • being treated for HNC in whom a ND is part of their care
  • willing and able to provide informed consent
  • able to understand written English
  • willing to attend the physiotherapy outpatient department if randomised to the GRRAND intervention arm
  • who remain eligible post-operatively when reviewed prior to randomisation

Exclusion criteria:

The participant may not enter the study if ANY of the following apply:

  • if treatment is palliative (expected survival six months or less)
  • those with a pre-existing, long-term neurological disease affecting the shoulder e.g. hemiplegia