CompletedInterventional

User experience study of digital tools to collect data on wellbeing and side effects in cancer patients

This study explores how new digital tools can help cancer patients in early drug trials share how they're feeling and any side effects they experience. Traditionally, quality of life is checked using paper forms, but this study uses apps on phones to collect information through videos or digital questionnaires. The goal is to see if these digital methods make it easier for patients to report symptoms and offer more insights than traditional methods. By doing this, researchers hope to improve how new cancer treatments are understood and developed, making sure patients' experiences are heard. The study is running from January 2024 to December 2025 and is funded by the European Union.

At a glance

Status

Completed

Sponsor

The Netherlands Cancer Institute

Enrolment target

Start

17 Mar 2025

Estimated completion

31 Oct 2025

All patients enrolled in phase I or II anticancer drug trials

What is this study about?

When new cancer medicines are being tested, it's really important to understand how they affect patients' daily lives and if they cause any side effects. Doctors usually give patients questionnaires to fill out, but these might not always capture everything or let patients share their experiences in their own words. This study wants to try a new way of collecting this information using digital tools, like apps on your phone.

We know that side effects can make a big difference to how someone feels, and if they're not tracked properly, it can lead to bigger problems like emergency hospital visits. This study aims to make it easier for patients to share how they're doing by using apps. This gives patients a stronger voice in clinical trials and helps doctors get a fuller picture of how new treatments are truly affecting people, rather than just what doctors observe. Over the last 10 years, it's become clear that patients often have different ideas about what's important for their quality of life compared to their doctors.

This study builds on previous research and introduces a new system called PROACT 2.0. This system lets patients share how they feel and function using text, voice notes, videos, or digital questionnaires. It can also send useful information back to patients and their caregivers. For this study, we're focusing on two parts of PROACT 2.0: video recordings and a digital questionnaire. We want to see how well these work in a real-life hospital setting with many different patients. By doing this, we hope to find better ways to understand and improve cancer treatments.

Key takeaways

New digital tools are being tested to help cancer patients share their experiences.
This study focuses on using apps for daily reports of feelings and side effects.
Participation involves using an app or filling questionnaires for 4 weeks.
There are no direct risks, and your input can help improve future cancer care.
The study aims to give patients a stronger voice in clinical trials.

Who may be eligible?

This study is looking for volunteers who are already taking part in an early-stage (Phase I or II) clinical trial for a new cancer drug. You need to be 18 years old or older, with no upper age limit given.

To join this study, you must be able to give your informed consent in writing. This means you understand what the study involves and agree to take part. You also need to be comfortable using mobile phone apps, or have a family member or friend who can help you use them.

However, you won't be able to join if you're already in a very similar study that asks you lots of questions about your quality of life, and if adding this study would make it too difficult for the main trial to measure things properly. Your doctor will help decide if this applies to you.

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 currently taking part in a Phase I or II cancer drug trial?
Are you 18 years old or older?
Can you comfortably use a mobile phone app, or do you have someone who can help you?
Are you able to sign a consent form to show you agree to take part?
Is your existing cancer trial not measuring quality of life in a way that would conflict with this study (your doctor can advise)?
Are you happy to dedicate 4 weeks to reporting your experiences?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through a check-up period for your cancer treatment trial. During this time, you'll fill out a questionnaire for *this* study about your quality of life. Then, on the first day you start your new cancer treatment, you'll be put into one of three groups for this study:

1. **PROACT 2.0 video group:** You'll use the PROACT app every day for 4 weeks. You'll record short videos talking about how you're feeling and any side effects you might have. There's no script, so you can just talk freely. 2. **PROACT 2.0 digital questionnaire group:** You'll use the PROACT app every day for 4 weeks. This app will ask you questions about any side effects you're experiencing through a digital questionnaire, and it will be the same set of questions each day. 3. **Quality of Life monitoring group:** You won't use the app daily. Instead, you'll fill out a standard quality of life questionnaire during your regular hospital visits over the same 4-week period.

After 4 weeks, if you were using the app, you'll stop. Then, at your next hospital appointment, you'll complete the standard quality of life questionnaire again, and a final questionnaire about your overall experience in this study. The study itself runs from January 2024 to December 2025.

Potential risks and benefits

There are no known risks involved in taking part in this study. The main benefit is that you'll have an opportunity to share your experiences and feelings about your cancer treatment in a new way, potentially helping future patients and improving how new medicines are understood. Your participation could help researchers learn more about how to best collect information from patients, making a valuable contribution to medical research. Remember, you can choose to stop participating in the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England

Common questions

What is the main goal of this study?

The study aims to find better digital ways for cancer patients to report their feelings and side effects during early-stage drug trials.

Who can take part in this study?

Adults (18-100 years old) who are in a Phase I or II cancer drug trial and can use smartphone apps, or have a helper, can participate.

What do I have to do if I join?

You'll be in one of three groups for 4 weeks: recording daily videos, answering daily digital questionnaires, or completing quality of life questionnaires at hospital visits.

Are there any risks to joining?

No, there are no known risks to taking part in this study.

Who is funding this research?

The study is funded by the European Union's Horizon 2020 programme for Research & Innovation.

How to find out more

Debra Joy Hall

debrajoy.hall@nhs.net +44 (0)1223 216083 Official trial record

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