RecruitingOBSERVATIONAL

APACE - Feasibility of Using Accelerometers to Measure Physical Activity in Cancer Patients on Early Phase Clinical Trials

This study, called APACE, aims to explore how wearable devices like accelerometers can be used to track physical activity and sleep in people with advanced cancer who are taking part in early-stage clinical trials. We know that being active can help cancer patients, but it's hard to measure accurately, especially for those on complex treatments. Many cancer patients also experience tiredness (fatigue). By getting better at measuring activity and sleep, we hope to improve how we manage fatigue, offer the right support, and ensure people can access suitable treatments. This is an observational study, meaning participants will wear a device for a few weeks without changing their usual treatment, and some will try a food survey app.

At a glance

Status

Recruiting

Sponsor

University of Manchester

Enrolment target

Start

28 Sep 2023

Estimated completion

30 Sep 2025

Cancer

What is this study about?

This study is called APACE and it's designed to help us understand more about how cancer patients experience their daily lives, specifically their physical activity and sleep patterns. We know that staying active can be really good for people with cancer, and it can help with common issues like fatigue (extreme tiredness). However, it's often difficult to accurately measure how active someone is, especially when they are already undergoing demanding treatments as part of an early-stage clinical trial.

At the moment, physical activity is sometimes used to see if someone can join a trial, so getting clearer information is important. This study hopes to find a good way to measure these things accurately using a small wearable device that tracks movement. This information could then help doctors and nurses provide better care, manage fatigue more effectively, and ensure patients get access to the treatments that are right for them.

This is an 'observational' study, which means you wouldn't be given any new medicine or treatment specifically for this study. Instead, if you choose to take part, you would wear a device that tracks your activity and sleep for about 5 to 6 weeks. This would happen alongside your usual trial activities and won't affect your treatment plan. Some participants will also be asked to try out a website called eNutri, which is a way to track what you eat, and share your thoughts on whether it's easy to use. The findings from this study will help us decide if these methods are practical and useful for cancer patients in the future.

Key takeaways

This study uses a wearable device to track physical activity and sleep.
It aims to improve understanding of how cancer patients experience daily life during treatment.
Participation will last for about 5 to 6 weeks and is observational (no new treatments).
Findings could lead to better support and management of fatigue for future cancer patients.
You can optionally try a food tracking website called eNutri and give feedback.
Your cancer treatment will not be affected by taking part.

Who may be eligible?

To join this study, you need to be at least 16 years old and have already agreed to take part in another early-stage cancer clinical trial. It's really important that you are willing to wear a small device for about five to six weeks and are happy to follow the study's simple instructions. Also, your doctor will assess your general health and fitness level using a common scale (called ECOG PS 0 or 1), which means you need to be able to look after yourself and do most daily activities.

There are a few reasons why you might not be able to join. For example, if your doctor believes that you wouldn't be able to stick to the study's requirements, or if you aren't eligible for the main early-stage clinical trial you were originally considering. The main aim is to make sure you can comfortably take part without it adding any extra stress or difficulty to your ongoing treatment.

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 at least 16 years old?
Are you currently participating in, or about to start, an early-stage cancer clinical trial?
Are you willing and able to wear a small device for about 5-6 weeks?
Are you generally able to look after yourself and perform most daily activities?
Are you happy to follow simple study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will wear a small, wearable device, similar to a fitness tracker, for about 5 to 6 weeks. This device will quietly collect information about your physical activity and sleep patterns. You will not need to attend extra visits or have additional medical appointments just for this study. It runs alongside your main clinical trial and doesn't involve any new medication or treatment. Some participants will also be invited to try a website called eNutri, a food diary, and provide feedback on how easy it is to use. The total duration of active participation is approximately 5 to 6 weeks.

Potential risks and benefits

Taking part in this study is generally considered low-risk, as it is observational and does not involve new treatments or medical procedures. The main involvement is wearing a device, which should not cause discomfort. You are free to withdraw from the study at any time without giving a reason, and this will not affect your ongoing care or treatment. While there may not be a direct personal benefit to you, your contribution will be invaluable in helping researchers understand how to better measure activity and sleep in cancer patients, which could lead to improved support and care for others in the future.

Locations (8)

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

National Cancer Institute of Milan (INT)
Verified postcode
Milan, Italy· Recruiting
Vall d'Hebron Institute of Oncology (VHIO)
Verified postcode
Barcelona, Spain· Recruiting
START Madrid CIOCC
Verified postcode
Madrid, Spain· Not yet recruiting
START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital
Verified postcode
Madrid, Spain· Not yet recruiting
Clínica Universidad de Navarra
Verified postcode
Pamplona, Spain· Recruiting
Instituto de Investigación Sanitaria (INCLIVA)
Verified postcode
Valencia, Spain· Recruiting
University Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Completed
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Completed

Common questions

What is an accelerometer?

An accelerometer is a small device, often worn like a watch, that measures movement and can help track your physical activity and sleep patterns.

Will this study affect my cancer treatment?

No, this study is completely separate from your cancer treatment and will not change your clinical care pathway in any way.

Do I have to try the eNutri website?

No, using the eNutri website is optional. You can choose to participate in the main part of the study without trying eNutri.

How long will I need to wear the device?

You will need to wear the wearable device for approximately 5 to 6 weeks.

What happens to the information collected?

The information collected will be used by researchers to understand how useful wearable devices are for tracking activity and sleep in cancer patients on early trials, ultimately aiming to improve patient care.

How to find out more

Gayle Patterson

gayle.patterson@manchester.ac.uk 07919719013 Official trial record

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