A trial comparing different methods of follow up after treatment for head and neck cancer (PETNECK2)

This is a phase 3 trial. The team need 698 people to take part.

It is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The 2 groups are:

• PET-CT scan guided patient led follow up
• usual follow up appointments 

PETNECK2 - Randomisation

Patient led follow up (the new method)
About a year after treatment you have a PET-CT scan. When the results are available a member of the trial team will discuss the results with you. 

If the scan shows that the cancer may have spread, come back or the result isn’t clear you then have some further tests to find more out. If these tests show the cancer has come back your doctor will talk to you about what treatment is best for you. You stay in the trial. You see the head and neck team as part of the usual follow up group.  

If the scan results are clear you then have a teaching session with a healthcare professional. They could be a:

• nurse
• clinical nurse specialist
• speech and language therapist
• dietitian

They will tell you about what signs and symptoms to look out for that might mean your cancer is coming back. They will answer any questions you might have. The session takes about 20 to 30 minutes. 

You take home information about this. You can choose to have the information:

• as a booklet
• as an app 
• as a link to a website

A member of the team will explain how to access the information and how to use it. They will also explain what to do if you have any concerns and how to contact your healthcare team. 

You will have access to the PET-CT scan mobile phone application (app). A member of the team will tell you how to access the app and what you can do with it. This includes a symptom diary where you record any signs or symptoms you might have. There are also videos on the app that can show you how to check yourself.

You do not have a follow up appointment to see the healthcare team. You do have an open urgent appointment. This means if you contact the healthcare team you will see them within 2 weeks of doing so. This appointment is in the head and neck follow up clinic. 

This does not reduce your access to the head and neck team. It means you can see the team when you need to. 

Usual follow up appointments (the current method)
This is the standard follow up. You see the head and neck team at regular times in the clinic. Your doctor will explain this to you, but it is usually every 2 to 4 months in the second year after the end of treatment. You then have them every 3 to 6 months for 3 years. 

Everyone (both groups)
The trial team will look at your medical records to gather information about your treatment and follow up care. 

Questionnaires
You fill in some questionnaires:

• before you go into one of the groups
• then at 6 months
• 1 year 
• 2 years

The questions ask about:

• your general health and wellbeing 
• what you are able to do
• symptoms
• any concerns you have
• what other health services such as your GP you use

These are quality of life questionnaires. 

Sub studies
There are sub studies in this trial. 

One sub study is about your follow up and how it affects your concerns and fear of the cancer returning. You have 2 separate interviews with a team member, one after you enter the trial and the other 1 year after that. They will arrange these at a time and place convenient for you. The interviews could be over the phone, face to face, by video call or email. You can choose which is best for you. 

Another sub study is about how doctors and nurses explain the PETNECK2 study to you.  A team member will interview you. They will arrange this at a time and place that suits you best. 

A member of the team will tell you more about these sub studies when they see you.  

You don’t have to agree to take part in either of these sub studies if you don’t want to.

Samples for research
The team will ask about taking samples of tissue and blood for research. This is to learn more about head and neck cancer and to look at genes  in cancer cells. You don’t have to agree to have these done if you don’t want to.