Clinical Trial

A clinical trial is a scientific way of testing new medicines, treatments or new ways of doing things. People volunteer to take part in the trial and researchers watch closely to see how well it works. Clinical trials have to be approved by the authorities before they can start to make sure that they are safe for the participants.

Vrouw op tablet LR

The goals of the PRE-ACT clinical trial

In the PRE-ACT project, we are creating a tool ('the app') to predict the chance of side effects of radiotherapy treatment for patients with breast cancer, including arm swelling. The tool will predict this risk for each individual patient. If the tool shows that someone has a high chance of arm swelling, they will be offered a special sleeve, designed to help with the swelling. With the clinical trial, we want to show that using this tool, and sometimes the sleeve, keeps the level of arm swelling the same or less than regular treatment without the tool does. This means that we want to make sure that the new treatment, in this case the tool, works without causing any harm.

Check whether it is really a feasible study

In the trial, we will also check other important things. We will look at the decisions that patients make about their treatment and whether those change when the tool is used. Also, we will ask the participants about their quality of life to see if this changes when using the tool.

Dokter onderzoekt vrouw klieren LR

How will the clinical trial be run?

This study was developed by a team of doctors, scientists, and former breast cancer patients, and has been approved by ethics boards in the Netherlands, France, and the United Kingdom.

The study is being carried out in hospitals in these three countries. Your doctor may invite you to take part. To understand how helpful the new AI tool is, we are comparing two groups of patients:

  • One group (the control group) will receive the usual advice and care. Your doctor will talk to you about the general risk of developing lymphedema after radiotherapy, based on medical experience and the latest research.
  • The other group (the intervention group) will receive an individual risk prediction using the new AI tool. This prediction is based on your personal medical data and will be discussed with you by your doctor.

If you choose to take part, you will be randomly assigned to one of the two groups. Neither you nor your doctor can choose the group.

Patients in both groups will be able to choose whether or not to wear a special compression sleeve, which may help reduce swelling. By comparing these two groups, researchers can see if the AI tool leads to better predictions and more helpful care.

Who can take part?

In principle, any female breast cancer patient from any of the registered hospitals can participate. However, there are some medical criteria that determine who can take part. Shortly: 

  • You have been diagnosed with breast cancer and are discussing your treatment options with your oncologist. Radiotherapy (radiation treatment) may be recommended.
  • You live in the Netherlands, France, or England, and your oncologist is participating in this study. Participation is completely voluntary; you are under no obligation to join. 
  • Your oncologist and team will talk to you about the study, give you written information, and give you the chance to go away and think about it, along with family, friends or your GP if you wish.  

You can read all requirements here. It is best if you ask your doctor about these criteria. He/she can also provide you with the right information.

Patients who want to participate must complete several questionnaires at intake, after three months of treatment, after 1 year and after 2 years. You will also - optionally - be asked to donate 2 tubes of blood. Please note that this is not compulsory. You can also participate without the blood donation.

At this moment the participating hospitals are not yet known. More information will follow as soon as possible. 

What you need to do when participating in the study

If you decide to join the study, there are a few simple steps to follow—both during your treatment and afterward. Here’s what you can expect:

  • If you decide to participate, you will be asked to sign a consent form.  
  • If you are in the group using the AI tool, you will be given an individual prediction of the likelihood of developing lymphedema after radiotherapy. Your oncologist will discuss this prediction with you.
  • If you are not in the group your oncologist will estimate the risk of developing lymphedema for people like you, based on their medical knowledge and the latest available scientific data.  
  • In both cases, you and your oncologist will decide together on the best treatment option for you.
  • After your treatment, you will receive ongoing questionnaires which you need to fill out. Questions include whether you developed lymphedema, and whether you experienced any other side effects.
  • Likewise your oncologist will report back on whether you received radiotherapy, whether you developed lymphedema, and , whether you experienced any other side effects.
  • By analyzing data from many participants, researchers can assess whether the AI tool provides a more accurate prediction of lymphedema risk than an oncologist relying on experience alone. afterwards

Data protection

Your data will be stored anonymously and used only for group analyses. The PRE-ACT research project complies with European privacy regulations, including the General Data Protection Regulation (GDPR). The GDPR is officially established in Regulation (EU) 2016/679 of the European Parliament and the Council of 27 April 2016.