“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial comparing different methods of follow up after treatment for head and neck cancer (PETNECK2)
More about this trial
Once you have finished treatment your doctor sees you in a routine follow up clinic. This is usually every 3 to 6 months for 5 years.
One thing the doctors check is whether the cancer has come back (recurrence). The sooner doctors know about cancer recurrence the sooner you can start treatment. The sooner you start treatment the better it is.
Some people feel that this amount of follow up is too much and too frequent. This can increase their anxiety about cancer recurrence.
People can ask to see their doctor if their symptoms change. We know from research that doctors are more likely to find cancer recurrence when this happens.
We also know from other studies that a
Researchers have developed a patient led follow up method that is guided by a PET-CT scan. This is different to standard follow up. In this trial they will compare these 2 types of follow up.
The aims of the trial are to find out:
- whether it is possible to do PET-CT scan guided patient led follow up
- how acceptable this type of follow up is for patients and doctors
- how well patient led follow up works
- how it affects
quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial 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 trial if you have had treatment for one of the following:
- mouth (oral) cancer
- laryngeal cancer
- nasopharyngeal cancer
- oropharyngeal cancer
Also, all of the following must apply. You:
- had treatment with the aim to cure at least 6 months ago and now you have no signs that the cancer has spread or has come back
- had a
squamous cell cancer
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have cancer that spread to the nearby tissue (locally advanced) or to another part of the body
- have cancer that has spread to the head and neck from elsewhere in the body and the doctors can’t find where the cancer started. This is called a cancer of unknown primary.
- are pregnant
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
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:
- 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.
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
- any concerns you have
- what other health services such as your GP you use
These are quality of life questionnaires.
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
Patient led follow up
You have 2 visits to the hospital. One is for the PET-CT scan. The other is for the teaching session.
You also have an open urgent appointment if you need it. This means you don’t have a date for an appointment but can ask to have one if you need one.
Clinic led follow up
You see the doctor as usual.
A PET-CT scan is a safe test. During the scan you are exposed to a very small amount of radiation. This can increase your risk of developing another cancer in the future but it is a very small risk.
If you choose to do the interviews you might find talking about your cancer and the follow up upsetting. You can ask for a short break if you need one.
The person doing the interview has experience in asking about sensitive issues. They can give the contact details of support groups.
Your doctor or a member of the trial team will talk to about the trial before you agree to take part. They will answer any questions you might have.
We have information about head and neck cancers.
How to join a clinical trial
Professor Hisham Mehanna
Mr Paul Nankivell
Cancer Research UK Clinical Trials Unit Birmingham
NIHR Programme Grants for Applied Research (PGfAR)
University of Birmingham