To Assess the Contribution of Sophrology Assisted by an Ambulatory Device on the Anxiety of Patients Undergoing Chemotherapy for the Treatment of Localized Breast Cancer
This study is exploring whether sophrology, a type of relaxation and mindfulness, can help women with breast cancer manage anxiety while having chemotherapy. Many women experience anxiety and depression after a cancer diagnosis, especially when undergoing treatments like chemotherapy. Sophrology is a supportive therapy that teaches techniques to balance thoughts, emotions, and body awareness, similar to mindfulness meditation. While sophrology is used in healthcare, there isn't much strong scientific evidence yet, especially in cancer care. This trial also looks at using a device called Morphee, which allows patients to do sophrology sessions at home. The goal is to make these helpful relaxation techniques more accessible to everyone, no matter where they live or their financial situation, to improve their quality of life during treatment.
At a glance
What is this study about?
When women are diagnosed with breast cancer, they often go through a lot of treatment, which can include surgery, chemotherapy, radiotherapy, and other therapies. This can be a very challenging time, and it's common for patients to feel anxious or even depressed. In fact, studies show that many patients feel anxious when they first hear they have cancer, and this can get worse during treatments like chemotherapy, particularly for younger women.
To help with these feelings and to improve overall quality of life, many support services are available, such as psychologists, exercise programs, and artistic therapies. Sophrology is one of these supportive therapies. It's a method that helps you become more aware of your body, thoughts, and feelings, and aims to strengthen positive actions. It uses relaxation and mindfulness techniques to help you find a better balance between your mind, emotions, and actions. It's a bit like meditation and is designed to boost your inner resources and well-being.
While sophrology is already used in many medical settings, healthcare experts have noted that we need more robust scientific studies to truly understand how much it helps cancer patients. This study aims to fill that gap. It's also looking at a device called Morphee. The idea behind this device is to make sophrology sessions easier to access for everyone. Sometimes, attending in-person sessions can be difficult due to travel, cost, or simply not having enough trained people available. The Morphee device would allow patients to do sophrology whenever and wherever they need it, potentially helping more women manage their anxiety during chemotherapy.
Key takeaways
- This study explores sophrology for anxiety in breast cancer patients during chemotherapy.
- Sophrology is a relaxation and mindfulness technique that aims to improve well-being.
- A device called Morphee helps make sophrology sessions accessible at home.
- The study aims to provide scientific evidence for sophrology's benefits in cancer care.
- It's a supportive therapy, used alongside regular cancer treatments, not instead of them.
Who may be eligible?
This study is looking for women aged 18 or over who have breast cancer localized to the breast area and who are about to start chemotherapy. You must be able to understand and speak French to take part, and you shouldn't have been treated with chemotherapy for breast cancer before.
There are some reasons why you might not be able to join. For example, if your breast cancer has spread to other parts of your body (metastatic), or if you have a history of certain serious mental health conditions like schizophrenia. You also can't participate if you've already had sophrology for your cancer or are planning to start it on your own within the next three months. This is because the study wants to see the unique effect of the sophrology offered through the trial.
If you have problems understanding or participating due to cognitive difficulties, or if you are already involved in another study testing a similar kind of supportive care, you wouldn't be able to join. The aim is to ensure that everyone in the study can fully understand and follow the instructions.
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 a woman aged 18 or older with breast cancer?
- Are you about to start chemotherapy for your breast cancer?
- Has your breast cancer not spread to other parts of your body?
- Do you speak and understand French?
- Have you NOT had chemotherapy for breast cancer before?
- Do you NOT have a history of serious mental health conditions or are currently on certain psychiatric medications?
What does participation involve?
If you decide to take part in this study, you would receive sophrology sessions. These sessions will be assisted by a special device called Morphee, which you can use at home. The study will track how these sessions affect your anxiety levels during your chemotherapy treatment for breast cancer. The exact number of sessions and how long you'll use the device will be explained in detail by the study team. You'll likely fill out questionnaires or have discussions to assess your anxiety levels and how you're feeling throughout your treatment. The study's duration will align with your chemotherapy treatment plan, with some follow-up afterwards to see the ongoing effects.
Potential risks and benefits
Locations (3)
- Institut de Cancérologie de l'Ouest - site AngersVerified postcodeAngers, France· Recruiting
- CH CholetVerified postcodeCholet, France· Active not recruiting
- Institut de Cancérologie de l'Ouest - site Saint HerblainVerified postcodeSaint-Herblain, France· Active not recruiting
Common questions
What is sophrology?
Sophrology is a relaxation method that uses breathing exercises, gentle movements, and visualisation to help you feel calmer and more in tune with your body and mind. It's similar to mindfulness and aims to reduce stress and anxiety.
What is the Morphee device?
The Morphee device is a tool that helps you do sophrology sessions at home. It makes these relaxation techniques more accessible, so you can use them whenever you need them, without having to travel for in-person sessions.
Will sophrology replace my regular cancer treatment?
No, absolutely not. Sophrology is a complementary therapy, meaning it works alongside your standard medical treatments like chemotherapy. It's there to support your well-being, not to replace any part of your main cancer care.
What if I don't feel better after sophrology?
It's important to remember that not all treatments work for everyone. If you don't feel better, or if you feel worse, you should always discuss this with your medical team. Your doctors will continue to ensure you receive the best care for your cancer and any side effects.
Is sophrology safe to do during chemotherapy?
Yes, sophrology is generally considered safe. It's a gentle technique focused on relaxation. The study team will make sure it's appropriate for you before you start.
How to find out more
Victor Simmet, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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