RecruitingOBSERVATIONAL

Description of Neurocognitive and Psychiatric Disorders Associated With Targeted Therapies Used in the Treatment of Lung Cancers With ALK/ROS1 Fusion and Their Impact on Patients' Quality of Life: Construction of an Experimental Patient-researcher Collaborative Care and Research Pathway

This study, called DRACONIS, focuses on understanding brain-related changes, like memory problems or mood swings, that some people with lung cancer experience when taking certain targeted medicines. These medicines are very effective for a specific type of lung cancer (ALK/ROS1 fusion) but can have side effects that affect thinking, feelings, and everyday life, sometimes more so than chemotherapy. The research wants to clearly describe these brain changes and find out how they affect patients' lives. By working closely with patients, doctors, and researchers, the study hopes to create better ways to identify, understand, and support people experiencing these side effects. It's about making sure future care pathways consider the whole patient.

At a glance

Status

Recruiting

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

16 Jan 2025

Estimated completion

09 May 2027

Metastatic Lung Cancer Metastatic Lung Cancer With ALK/ROS1 Fusion

What is this study about?

This study, called DRACONIS, is looking into how certain new cancer medicines affect people's brains. These medicines are very good at treating a specific type of lung cancer, called ALK/ROS1 fusion lung cancer, and can help people live longer, sometimes even for many years. However, doctors have noticed that these powerful medicines can sometimes cause changes in how people think, remember things, or feel emotionally. These changes can range from memory issues and trouble concentrating to anxiety, low mood, or even more unusual changes.

While these brain-related side effects, sometimes called 'neurocognitive and psychiatric disorders,' have been reported, we don't fully understand how common or severe they are, or how much they impact daily life. This is partly because current ways of studying and treating cancer haven't always focused on these particular side effects. The DRACONIS project aims to fill this gap. It wants to get a clearer picture of these brain changes through careful tests and by listening closely to patients' experiences.

A key part of this study is that it's a team effort. Researchers, doctors, and patient groups are working together. This means that patient experiences and concerns are right at the heart of the research. By carefully describing these issues and understanding how they affect quality of life, the study hopes to find better ways to support patients in the future, making sure that future cancer care considers all aspects of a person's well-being, not just fighting the cancer itself.

Key takeaways

This study aims to understand brain-related side effects of specific lung cancer drugs.
It focuses on memory, thinking skills, and mood changes.
The research involves careful assessments and listening to patient experiences.
Patients with ALK/ROS1 positive lung cancer currently on targeted therapy may be eligible.
The goal is to improve future care and support for patients.
It's a joint effort between doctors, researchers, and patient groups.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or over, and able to speak and understand French well. You must currently be taking one of the specific targeted medicines (called anti-ITK-ALK/ROS1) for ALK/ROS1-positive lung cancer. Importantly, your doctor must have noticed that you've been having some brain-related symptoms – either problems with thinking, memory, or changes in mood or behaviour – that they think are linked to your treatment.

You wouldn't be able to join if you had significant brain-related problems from before you started these specific cancer medicines, unless they were caused by other cancer treatments. Also, if your brain cancer (metastases) is not currently stable or is causing a lot of symptoms, or if you have other serious medical conditions that could make it hard to assess you accurately, then you unfortunately wouldn't be eligible. This includes things like severe uncontrolled epilepsy, active mental health conditions, or very poor eyesight or hearing that would prevent you from taking part in the assessments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 or older?
Can you speak and understand French well?
Are you currently taking an anti-ITK-ALK/ROS1 targeted therapy for ALK/ROS1-positive lung cancer?
Has your doctor noticed you've been having thinking, memory, or mood problems that might be linked to your treatment?
Do you have a stable medical condition (e.g., no uncontrolled brain cancer or severe other illnesses impacting assessments)?
Did you not have these specific brain problems *before* starting your current cancer treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have several assessments. These will involve careful tests to check your memory, thinking skills, and mood. These might include answering questionnaires and having some conversations with specialists to understand your experiences with these brain-related side effects. The study aims to get a detailed picture of your current situation. You won't be given any new medication as part of this study; it's purely about understanding the effects of your current treatment. The total duration of your involvement isn't specified, but it will involve a series of these assessments.

Potential risks and benefits

Taking part in this study won't directly improve your health, as it's about observing and understanding, not offering new treatments. However, a potential benefit is that your detailed input could help doctors and researchers better understand these side effects, potentially leading to improved care for patients like you in the future. The risks are generally low, mainly involving the time and effort required for the assessments, and perhaps some emotional discomfort when discussing your experiences. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (2)

Day care Hospital, Pierre Wertheimer Hospital, Civil Hospitals of Lyon
Verified postcode
Bron, France· Recruiting
Pneumology service, Louis Pradel Hospital, Civil Hospitals of Lyon
Verified postcode
Bron, France· Recruiting

Common questions

What kind of brain problems are they looking for?

They are looking for changes in thinking, memory, concentration, and mood, like anxiety, depression, or emotional changes.

Will I have to stop my current cancer medicine?

No, this study does not involve changing your current cancer treatment. It's about understanding the effects of the medicines you're already taking.

Who is running this study?

It's a collaborative effort between researchers, doctors, and a patient association for people with this type of lung cancer.

What will happen to the information I provide?

Your information will be used to better describe and understand these side effects, aiming to improve future patient care and support. Your privacy will be protected.

How long will I be involved in the study?

The information provided doesn't specify the exact duration, but it will involve a series of assessments to understand your experiences.

How to find out more

Michael DURUISSEAUX, Professor

michael.duruisseaux@chu-lyon.fr +33 4 72 35 76 44 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.