RecruitingNAINTERVENTIONAL

Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Head and Neck Squamous Cell Carcinoma (HNSCC)

This study is investigating a new way to support people being treated for a type of head and neck cancer. It focuses on using digital tools to keep an eye on patients' symptoms from a distance. The idea is that by noticing problems early, before they get serious, doctors can give better, more timely care. Researchers want to find out if this 'remote monitoring' approach can help reduce weight loss, a common issue for patients after radiotherapy or chemoradiotherapy. They hope that catching and managing symptoms quickly will lead to better overall health and fewer complications during and after treatment. This is about improving patient care and making the treatment journey easier.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Henri Becquerel

Enrolment target

192

Start

15 Oct 2025

Estimated completion

01 Jun 2030

Head and Neck Squamous Cell Carcinoma HNSCC

What is this study about?

This research study is all about finding better ways to support people who have a specific type of head and neck cancer, called squamous cell carcinoma. These patients often go through treatments like radiotherapy or a combination of radiotherapy and chemotherapy. Sometimes, side effects from these treatments, such as difficulty eating or swallowing, can lead to unwanted weight loss.

The study wants to see if using a special digital system to check symptoms from home can help. Imagine having a tool, perhaps on your smartphone, where you can regularly report how you're feeling. The medical team would then keep an eye on these reports. If they see that you're struggling with something, like not eating enough or feeling unwell, they can step in much sooner than before.

The main question the researchers want to answer is whether this early warning system, by helping doctors act quickly, can reduce the number of patients who lose a lot of weight (5% or more) after their treatment. They believe that by providing more timely support and care, patients will have a better experience and hopefully fewer complications.

Key takeaways

The study focuses on using digital tools to monitor head and neck cancer symptoms remotely.
It aims to see if early symptom detection can reduce weight loss after treatment.
Participation involves actively reporting your symptoms from home.
There are no new medicines involved in this monitoring study.
People aged 18-75 with specific head and neck cancer types may be eligible.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old. You must have been diagnosed with a specific type of head and neck cancer (squamous cell carcinoma) that doctors plan to cure with radiotherapy alone or with combined radiotherapy and chemotherapy. It's also important that you are generally well enough to take part and can understand what the study involves. You'll need to sign a consent form, meaning you agree to participate, and have access to a smartphone or the internet to use the remote monitoring system.

There are some reasons why you wouldn't be able to join. For example, if you've had another cancer recently (within the last two years) or if your cancer is spreading. If you've had radiotherapy to your head and neck area before, or if you are pregnant or breastfeeding, you also wouldn't be able to participate. They also can't include people who are already in another clinical trial looking at new treatments.

Finally, it's important that you can understand the study information and commit to what's needed. This means patients who have difficulty with language, have certain psychological challenges, or can't use the digital tool (for example, due to blindness) wouldn't be suitable for this particular study. This is to make sure everyone involved can safely and fully participate.

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 between 18 and 75 years old?
Do you have a type of head and neck cancer called squamous cell carcinoma, and is your doctor planning to cure it with radiotherapy or chemoradiotherapy?
Are you generally well enough (WHO score less than 2)?
Do you have access to a smartphone or the internet?
Have you NOT had another cancer in the last 2 years, or radiotherapy to your head and neck before?
Are you able to understand the study and commit to reporting your symptoms?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully provided in this summary. However, based on the study's aim, if you join, you would likely be asked to regularly report your symptoms using a digital tool, probably on a smartphone or through an internet portal. This remote monitoring would likely go on for a period of time, perhaps for several months after your radiotherapy or chemoradiotherapy treatment. You would continue to receive your usual medical care, but the remote monitoring would be an added layer of support. You wouldn't be taking any new medicines as part of this study.

Potential risks and benefits

Taking part in this study might offer the benefit of earlier detection and management of symptoms, potentially leading to better health outcomes and a more comfortable recovery after treatment. There are generally no new medical risks associated with remote monitoring itself, as it's designed to provide support. However, it requires you to actively engage with the digital tool and report your symptoms. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Centre Henri Becquerel
Verified postcode
Rouen, France· Recruiting
Institut de Cancérologie de Lorraine
Verified postcode
Vandœuvre-lès-Nancy, France· Not yet recruiting

Common questions

What is remote monitoring?

Remote monitoring means doctors keep an eye on your symptoms from a distance, often using a digital tool like an app on your phone, so you don't always have to come to the hospital.

Why is this study important?

It's important because it aims to find out if checking symptoms regularly from home can help catch problems early, potentially reducing common issues like weight loss after cancer treatment.

Do I have to use a smartphone?

The study mentions needing access to a smartphone or the internet, so you'd likely use a digital device to report your symptoms.

Will I get new medicine in this study?

No, this study is about how symptoms are monitored, not about testing new medications. You'll still receive your standard cancer treatment.

What if I decide to stop participating?

You are free to stop participating at any time without having to give a reason, and it will not affect the medical care you receive.

How to find out more

Sebastien Thureau, MD,PhD

sebastien.thureau@chb.unicancer.fr +33232082992 Official trial record

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