A study looking at physiotherapy after surgery for head and neck cancer (GRRAND)

Cancer type:

Ear cancer

Head and neck cancers

Laryngeal cancer

Mouth and oropharyngeal cancer

Nasal and paranasal sinus cancer

Oesophageal cancer

Salivary gland cancer

Tongue cancer

Tonsil cancer

Status:

Open

Phase:

Phase 3

This study is looking at whether physiotherapy sessions after hospital discharge will help people recover after surgery.

It is for people who have had surgery to remove lymph nodes Open a glossary item in their neck. This is called a neck dissection.

More about this trial

For head and neck cancer you may have an operation to remove some or all of the lymph nodes in your neck. This type of surgery is called a neck dissection Open a glossary item . It is usually done if there is a chance that the cancer might have spread to the lymph nodes.

You stay in hospital after surgery. While you are in hospital you see your surgeon, the cancer team and a physiotherapist Open a glossary item . This is the usual NHS care after surgery.

You have physiotherapy to help ease the pain and improve movement after surgery.

When you go home from hospital, you don’t usually have further physiotherapy as part of your routine NHS care.

After having a neck dissection some people have problems with shoulder and neck movement. This can affect everyday tasks including dressing, household chores, driving, carrying shopping bags and gardening. Researchers are looking at ways to help people recover. They think that having more physiotherapy sessions could help.

In this study, some people will have usual NHS care after their surgery. And some
will have usual NHS care after their surgery and up to 6 extra sessions of physiotherapy after they go home.

These extra physiotherapy sessions have already been designed for people who have had a neck dissection.

The main aims of the study are to find out:

if adding extra physiotherapy sessions to usual NHS care improves recovery
more about quality of life

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

have head and neck cancer and you are going to have a neck dissection as part of your treatment. This is treatment with the aim to cure.
can go to the outpatient department at the hospital for your extra physiotherapy sessions
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. You:

need to have intensive physiotherapy when you go home from hospital. Your doctor will know this.
already have a long term problem or condition affecting your shoulder
have already had a neck dissection on the affected side
are having only a tissue sample (biopsy ) taken from a lymph node or from a sentinel lymph node in the neck. You might be able to take part if you then have a neck dissection after having the biopsy.
have already taken part in this study
can’t take part for any other reason

Trial design

This is a phase 3 study. The team need 390 people to take part.

It is a randomised study. A computer puts you into a group. Neither you nor your doctor will be able to decide which group you are in.

There are 2 groups. You have 1 of the following:

usual care after neck dissection surgery
usual care after neck dissection surgery and up to 6 extra physiotherapy sessions

GRRAND diagram

Usual care group
If you are in the usual NHS care group, you will have physiotherapy while you are in hospital. This will include home exercises to continue to help strengthen your arms and neck. If you need more physiotherapy, your surgeon or the physiotherapist will arrange this.

Extra physiotherapy sessions group
You will have physiotherapy while you are in hospital as part of your routine care.

You also have up to 6 sessions of physiotherapy when you go home. This will start within 2 weeks. You have the sessions as an outpatient at the hospital.

Each session takes up to an hour. At each appointment, the physiotherapist Open a glossary item will see how you are getting on. They will work out whether there are any problems that are slowing your recovery and see how best to help with these problems. The aim is to help you to regain your strength and mobility. They may give you exercises to do each day or a programme of exercises to follow.

A researcher from the study team may attend some of your physiotherapy appointments. This will either be in person or online with a video consultation. This is to check how the treatment is being given. They hope this will help to see that the sessions are being run correctly.

Quality of life
The study team asks everyone to fill out some questionnaires:

before you have surgery
6 weeks after surgery
at 3 months
at 6 months
at 12 months

The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.

They take 20 to 30 minutes to fill in each time.

You can complete these online or fill them in on paper. You return the paper questionnaires in the post using the pre-paid envelope provided. If you can’t complete them online or return them by post, the team could call you and collect this information over the phone.

Interviews
You might be invited to take part in a short interview. This is to ask you what you thought about the study and the physiotherapy sessions.

You don’t have to take part in the interview if you don’t want to. It won’t affect you taking part in the rest of the study.

Hospital visits

You have up to 6 extra hospital visits if you are in the physiotherapy group. You shouldn’t have any extra visits as part of the study if you are in the usual care group.