RecruitingPHASE3INTERVENTIONAL

Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only

This study is a Phase 3 clinical trial investigating a digital tool called Resilience PRO. It's designed for people with cancer who are receiving treatment. Resilience PRO is a mobile phone application that regularly asks participants about their symptoms. If a symptom is important, the app sends an alert to their healthcare team. The main goal is to find out if using Resilience PRO can improve the quality of life for cancer patients. Researchers will compare patients using the app alongside their usual care to those who only receive usual care. This helps to understand if the extra support and communication provided by the app can make a positive difference in how patients feel day-to-day.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Resilience

Enrolment target

1,458

Start

01 Apr 2025

Estimated completion

01 Dec 2029

Cancer

What is this study about?

This study is looking into a new way to help people living with cancer who are having treatments. It's called Resilience PRO, and it's a mobile phone app. The main idea is to see if using this app can make a real difference to their quality of life – meaning how well they feel and cope with their daily life.

Here’s how it works: the app regularly checks in with patients about their symptoms. If there's something important going on with their health, the app can send a message straight to their healthcare team. This quick communication means the team can react faster and adjust their care if needed. The researchers want to know if this quick and regular checking in, and the fast response from the care team, helps patients feel better overall.

Some people in the study will use the Resilience PRO app along with their normal healthcare, while others will just receive their usual care. By comparing these two groups, the researchers can understand if the app truly helps improve how people live with cancer during their treatment. They believe that getting feedback on symptoms regularly and allowing the care team to respond quickly could be a big help.

Key takeaways

This study evaluates a phone app called Resilience PRO for cancer patients.
The app helps monitor symptoms and alerts your care team if needed.
The main goal is to see if the app improves quality of life during cancer treatment.
Participation involves using the app alongside your regular care.
You must be 18 or older, have cancer, and be receiving treatment to join.

Who may be eligible?

To join this study, you need to be an adult, age 18 or older, and have a diagnosis of cancer. You should also be receiving treatment for your cancer.

It’s important that you have access to a smartphone and can use it for the app. You also need to be able to understand and communicate in the language the study is being run in. Before joining, you'll need to sign a consent form, showing you understand and agree to take part.

However, some things would mean you can't join. For example, if you are under 18, or if your doctor believes your life expectancy is less than six months. If you are already using another remote monitoring system for your health, or if you've had certain complex cancer treatments like a stem cell transplant or CAR-T therapy, you might not be able to participate. Also, if you have issues with memory or thinking that would make it hard to use the app, or if you are pregnant or breastfeeding, you wouldn't be able to join. The study is open to both men and women.

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 years old or older?
Do you have a cancer diagnosis and are you currently receiving treatment?
Do you have access to a smartphone and can you use apps on it?
Can you understand and speak English (or the study language)?
Are you not currently pregnant or breastfeeding?
Do you have a life expectancy of more than 6 months, as estimated by your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive your usual cancer care. On top of this, if you are chosen for the 'intervention group', you will use the Resilience PRO mobile phone app. This app will regularly ask you about your symptoms. If you report symptoms that are important for your health, the app will send an alert to your healthcare team. This allows them to respond quickly and adjust your care if needed.

There won't be extra hospital visits or different medications specifically for this study. The main commitment is using the app consistently throughout the study period. The total duration of your participation will depend on the study's plan, but it will be explained in full detail before you agree to take part.

Potential risks and benefits

Taking part in this study may offer some benefits, such as potentially experiencing an improved quality of life through closer monitoring of your symptoms and quicker responses from your healthcare team. However, there are no guarantees of direct benefit to you personally. The main risk involves the time and effort required to regularly use the app. There's also the chance the app might not always work perfectly, but developers aim to make it as reliable as possible. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (36)

Hôpital Privé de Provence
Verified postcode
Aix-en-Provence, France· Recruiting
Centre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis
Verified postcode
Aix-en-Provence, France· Recruiting
Centre Hospitalier Henri Mondor-Aurillac
Verified postcode
Aurillac, France· Recruiting
Centre Hospitalier de la Côte Basque
Verified postcode
Bayonne, France· Recruiting
Centre Hospitalier Universitaire de Caen Normandie
Verified postcode
Caen, France· Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
Centre Hospitalier Universitaire Grenoble - Alpes
Verified postcode
La Tronche, France· Recruiting
GHICL Hôpital Saint Vincent de Paul
Verified postcode
Lille, France· Recruiting
Centre Hospitalier Universitaire de Lille
Verified postcode
Lille, France· Recruiting
Hôpital Privé Jean Mermoz - Institut de Cancérologie
Verified postcode
Lyon, France· Recruiting
AP-HM Assistance Publique - Hôpitaux de Marseille Hôpital de la Timone
Verified postcode
Marseille, France· Recruiting
Centre Hospitalier Universitaire de Nantes
Verified postcode
Nantes, France· Recruiting

Common questions

What is Resilience PRO?

It's a mobile phone app designed for cancer patients to report their symptoms regularly to their healthcare team.

Will my usual cancer care change if I join?

No, you will continue to receive your standard cancer treatment and usual care. The app is an addition to this.

Do I need a special phone to use the app?

You just need a smartphone and to be comfortable using apps on it.

What happens if I report a serious symptom on the app?

If you report a clinically important symptom, an alert is sent to your healthcare team so they can review and respond as needed.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.

How to find out more

Resilience

support@resilience.care +33 805 69 65 61 Official trial record

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