A study using an app to help with an exercise and diet programme before lung cancer surgery (Fit 4 Surgery 2)
Cancer type:
Status:
Phase:
This study is looking at an app to provide an individual exercise and diet programme to prepare for lung cancer surgery.
The app is called Fit 4 Surgery 2 or F4S-2 for short. It is for people who are having lung surgery with the aim to cure.
More about this trial
Physical exercise and healthy eating can help you to prepare for lung cancer surgery. It is called prehabilitation. It is available at some hospitals. It can help speed up recovery time after surgery and reduce complications. It isn’t yet clear what is the best way to deliver this for each person.
How much support you get with exercise goals and healthy eating can vary in different hospitals. A prehabilitation plan isn’t always available for people before lung cancer surgery. Some people might be offered exercise sessions or they might see a
A group of lung cancer healthcare professionals and patients have developed the Fit4 Surgery 2 App. It provides a personalised programme of exercises you can do at home. And ways to improve your diet before surgery. The team will compare this with the usual care people have before surgery to remove lung cancer.
The main aims of the study are to find out if the Fit4 Surgery 2 App:
- improves physical recovery after surgery
- reduces the risk of developing complications and their severity
- improves
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 lung cancer that started in the lung or your doctor suspects this
- are having surgery for lung cancer with the aim to cure
- are willing to use the F4S-2 App
- are able to take part in the F4S-2 programme for at least 2 weeks before your surgery
- are willing to fill in the study questionnaires
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have had emergency surgery to remove your lung cancer
- are being fed through a drip into your bloodstream (parenteral nutrition)
Trial design
This study is taking place in the UK. The team need about 900 people to take part.
A member of the research team asks you some questions about your general health. You then complete a set of questionnaires and do some physical tests. These include a:
- hand grip test
- one minute ‘sit to stand’ fitness test
- short walk test
These take around 40 minutes.
This is a randomised study. A computer puts you into 1 of 2 groups group. Neither you nor your doctor can decide which group you will be in. The 2 groups are:
- the usual care you have before surgery
- usual care and using the F4S-2 App before surgery
Usual care group
You can access the usual support services available at the hospital where you are having treatment. Before surgery, your team tell you where you can find information about:
- a healthy diet
- physical activity
App and usual care group
You can access the usual support services as described above. You also use the app.
The study team either lend you a tablet computer with the app on it. Or you download the app onto your smart phone or device. The team can help you with this if necessary and they can show you how to use it. There are also some short videos and a picture guide to help you.
The app asks some initial questions. This helps to create your own personal exercise and nutrition programme. It includes some strengthening, mobility and physical exercises to get your heart rate up. It tells you what you should be eating and drinking based on your needs.
The research team will answer any questions that you have about using the app. There is also a telephone helpline if you have any problems and a picture guide. If the team have provided you with a tablet computer, it will come with a SIM card which allows it to connect to the internet.
You use the app for at least 2 weeks before surgery. You can also use it for up to 6 weeks after surgery. The research team give you a smart watch to wear when you do your exercises. This monitors your heart rate.
Questionnaires and physical tests (both groups)
The team ask you to fill in some paper questionnaires. These ask how you are coping, how you feel physically and if you have any side effects. This is called a quality of life study.
You complete these:
- on the day of surgery
- 2 weeks after your surgery
- at 1 month
- at 3 months
- at 6 months
The questionnaires take about 10 to 15 minutes to complete each time. Once you go home the team post the questionnaires to you. They provide a freepost envelope for you to return the questionnaires to them. You can contact a member of the research team if you need help.
You also do the same physical tests you did when you joined the study. You do these:
- on the day of surgery (not including the walk test)
- on the day you go home from hospital (not including the walk test)
- at 1 month
Hospital visits
The study team don’t expect there to be extra visits to the hospital if you take part in the study.
Side effects
There aren’t any side effects as a result of taking part in this study.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Babu Naidu
Supported by
University of Birmingham
NIHR Health Technology Assessment (HTA) programme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040