Trial Status: In Closure
Head and neck cancer (HNC) 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. This study will start to answer this question.
Aims and objectives
To conduct a feasibility study to see if a rehabilitation treatment programme is acceptable for patients who have been discharged from hospital after surgery for HNC. The programme has been designed by physiotherapists and patients who have had HNC surgery.
This is a two-group, feasibility, randomised controlled trial.
60 patients who have had surgery for HNC, and who have agreed to participate in the study, will get either usual care, or usual care PLUS the study's new rehabilitation treatment programme. A computer will decide by chance which treatment regime they will get.
Usual care is treatment and information an NHS patient would usually get after they have had surgery for HNC. This will include in-patient physiotherapy and an advice leaflet on basic exercise and self-care following surgery; and may include referral for out-patient physiotherapy when they are discharged. The study treatment programme we are testing has extra rehabilitation treatment on top of this usual care. This will give patients up to 6 physiotherapy appointments over 6 months, which will include exercises and advice for managing pain, and coping with fatigue and common side-effects of HNC surgery.
To decide if the programme is acceptable to patients, we will look at how many of the people who are told about the study decide to join it; how long they stay in the study for; whether they keep doing their rehabilitation programme at home; and if they decided to get any other treatments themselves after their surgery. We will also interview some of the patients and physiotherapists at the end of the programme, and ask them what they thought of the study, and if there is anything they think could be improved.
The study protocol publication can be found here.
The primary publication can be found here.