All studies
Not yet recruitingNAINTERVENTIONAL

Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery

Doctors are studying a new way to help people recovering from surgery for digestive cancers. This type of cancer affects organs like the stomach, bowel, or liver. After these surgeries, problems like infections or pain can be common. The study is testing a mobile phone app called Maela. Patients use the app for 90 days after going home to track their symptoms. Their care team can see these updates and respond quickly if needed. The main goal is to see if using this app helps patients recover better and reduces issues compared to regular follow-up care that doesn't use the app. This could lead to fewer hospital visits and better overall health after surgery.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrolment target
555
Start
01 Nov 2026
Estimated completion
01 Nov 2027

What is this study about?

This study is about making recovery better for people who have surgery for digestive cancers, which are cancers affecting organs like the stomach, bowel, or liver. In the UK, these cancers are a significant health concern. After surgery, it's common for patients to face challenges like infections, breathing problems, blood clots, or ongoing pain. These issues can really affect how well someone recovers and their quality of life in the long run.

The research focuses on a new approach using a mobile app called Maela. When patients leave the hospital after surgery, they often go home with instructions on how to take care of themselves. This study wants to see if using the Maela app, which lets patients report their symptoms from home, can improve their recovery even more. Healthcare teams can keep an eye on these updates and step in quickly if a patient reports a worrying symptom. This remote check-in system has shown promise in other areas by helping to prevent unnecessary hospital stays.

The main aim of this study is to compare how patients recover using the Maela app versus those receiving standard care without the app. Doctors want to find out if the app helps reduce complications, improves overall health, and makes the recovery process smoother for people after digestive cancer surgery. This is important because, currently, no one has thoroughly checked if such an app makes a real difference compared to usual care.

Key takeaways

  • It's about making recovery better for digestive cancer surgery.
  • The study uses a mobile app for checking symptoms from home.
  • Doctors will compare app users to those getting standard care.
  • The goal is to reduce problems and improve well-being after surgery.
  • Participation involves using the app for 90 days post-surgery.
  • You need a smartphone and internet access to join.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and scheduled to have surgery for a digestive cancer such as cancer of the bowel, pancreas, liver, stomach, or gullet. Your surgery must be planned at least two weeks in advance.

You also need to have a smartphone (either an iPhone or Android phone) that you can use, or live with someone close to you who has one you can use. This phone must have internet access, either through mobile data or Wi-Fi. You should also be able to read and understand French as the app is currently in French, and you'll need to sign a consent form.

There are some reasons why you might not be able to join. For example, if you're already in another medical study, have certain serious mental health conditions, can't use a questionnaire even with help, or have severe vision, memory, or hand movement problems. The study also cannot include pregnant or breastfeeding women, or anyone without a mobile phone number or internet access.

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.

  1. Are you 18 years old or older?
  2. Are you having surgery for a digestive cancer (e.g., stomach, bowel, liver, pancreas)?
  3. Do you have a smartphone with internet access, or does someone you live with have one you can use?
  4. Can you read and understand French?
  5. Are you NOT currently part of another medical research study where you are receiving a specific treatment?
Answer every question to see your result.

What does participation involve?

If you join this study, you will use a mobile app called Maela for 90 days (about three months) after your surgery. Through this app, you'll answer questions about how you're feeling and any symptoms you might have. Your care team will be able to see your responses online and contact you if they have concerns. This will happen from your home, so you won't need extra hospital visits just for the study. Otherwise, your medical care will follow the usual pathway for someone recovering from your type of surgery. The total duration of your active participation will be these 90 days of using the app.

Potential risks and benefits

Participating in this study might offer the benefit of closer monitoring after your surgery, potentially allowing your care team to spot and address any problems sooner. This could lead to fewer complications and a smoother recovery. The main risk is that using the app might feel like an extra task during your recovery, but it is designed to be user-friendly. There's also a chance that the app might not provide any additional benefit compared to standard care. You are free to withdraw from the study at any time without affecting your medical care.

Locations (5)

  • CH Sud Francilien
    Verified postcode
    Corbeil-Essonnes, France
  • Hôpital Nord
    Verified postcode
    Marseille, France
  • CHRU Nancy Brabois
    Verified postcode
    Nancy, France
  • Hôpital Saint-Antoine
    Verified postcode
    Paris, France
  • CHU Rouen
    Verified postcode
    Rouen, France

Common questions

What kind of cancers is this study for?

This study is for people having surgery for cancers of the digestive system, like the stomach, bowel, liver, or pancreas.

What exactly is the Maela app?

The Maela app is a tool on a mobile phone that lets you track and report your symptoms after surgery. Your doctors can then see these updates.

How long would I use the app if I join?

You would use the Maela app and report your symptoms for 90 days, which is about three months, after your surgery.

Do I need my own smartphone?

Yes, you need to have a smartphone (iPhone or Android) with internet access, or live with someone who has one that you can use.

Will using the app change my medical treatment?

No, the app is to help monitor your recovery. Your medical treatment for your cancer and surgery will continue as usual.

How to find out more

Ugo Marchese, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of the Clinical Impact of the Numerique Medical D…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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