RecruitingNAINTERVENTIONAL

Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer

This study is investigating a special exercise programme for women who are currently undergoing treatment for breast cancer. French health authorities have recognised special exercise as a helpful, non-drug therapy, but we need more research during active treatment. The main goal is to compare this structured exercise programme with simply giving women general advice about physical activity. We want to see if the special exercise helps improve women's quality of life and potentially lowers healthcare costs. This research is important because while exercise is known to be beneficial, there are still some unknowns about how best to offer it during active breast cancer treatment and whether it can save money over time.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

866

Start

23 Dec 2024

Estimated completion

01 Dec 2027

Breast Neoplasm

What is this study about?

This study is all about helping women who are going through treatment for breast cancer. We know that conditions like breast cancer are unfortunately becoming more common, and treatments can be long and expensive. We're looking at a specific type of help called 'Adapted Physical Activity,' or APA. This isn't just regular exercise; it's a specially designed programme that takes into account your health and treatment.

Experts believe that these specially designed exercise programmes can help manage some of the difficult side effects of cancer treatment. This includes things like feeling very tired, losing muscle, gaining fat, and dealing with pain. There's already some evidence that exercise can help improve quality of life and even reduce the chances of cancer coming back for people who have finished treatment. However, we don't know as much about how effective these programmes are while people are still actively receiving treatment.

This study aims to find out if a structured Adapted Physical Activity programme is more beneficial than just getting general advice about exercise. We'll be looking to see if it makes a real difference to quality of life for women with breast cancer, and if it could even help reduce overall healthcare costs in the long run. By understanding this better, we hope to make these helpful exercise programmes more widely available and covered by health services in the future.

Key takeaways

This study evaluates special exercise for women with breast cancer.
It compares a structured exercise programme to general exercise advice.
The goal is to improve quality of life and potentially reduce healthcare costs.
Participants must be women actively undergoing breast cancer treatment.
The exercise programme lasts for six months after an initial check-up.

Who may be eligible?

This study is looking for women who have breast cancer and are currently receiving treatment, which could include surgery, chemotherapy, radiotherapy, or hormone therapy. We are interested in all types and stages of breast cancer.

However, there are certain health conditions that would prevent you from taking part. For example, if you have severe heart or breathing problems, recent serious heart issues, or unstable angina. You also can't join if you have very severe fatigue, severe pain, or certain bone problems. If you've had recent surgery, are pregnant or breastfeeding, or are already taking part in another similar study or exercise programme, you would not be able to participate. We also can't include anyone with certain severe infections or who has legal protective measures in place.

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 a woman with breast cancer?
Are you currently receiving breast cancer treatment (surgery, chemo, radio, hormone therapy)?
Are you generally stable, without severe heart or breathing issues?
Have you NOT had major surgery in the last three weeks?
Are you NOT pregnant or breastfeeding?
Are you NOT currently in another similar exercise study?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement would begin with an initial appointment. This appointment will include a medical check-up to make sure you're healthy enough to take part and some physical tests to understand your current fitness level. After this, you would then take part in a structured Adapted Physical Activity (APA) programme for six months. If you are in the 'comparison group', you would have the same initial medical check-up and physical tests, but instead of the structured programme, you would receive general recommendations and advice about physical activity.

Potential risks and benefits

Taking part in this study could potentially offer several benefits. You might experience an improvement in your quality of life, feel less fatigued, and better manage other side effects of your breast cancer treatment through the structured exercise programme. The main risks associated with physical activity are generally low, such as muscle soreness or minor strains; however, the initial medical check-up and physical tests are designed to ensure your safety. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Marie-Eve Rougé-Bugat
Verified postcode
Toulouse, France· Recruiting

Common questions

What is 'Adapted Physical Activity'?

It's a special exercise programme designed specifically for people with health conditions, taking into account their individual needs and treatment.

Who can join this study?

Women with any type or stage of breast cancer who are currently receiving active treatment.

How long does the study last?

The main part of the study involving the exercise programme will last for six months after your initial assessment.

Will this cost me anything?

The study aims to evaluate health costs, but it doesn't state that participation will cost you personally. Specifics would be discussed at your initial consultation.

What if I get tired or can't do the exercises?

The programme is 'adapted' for you, meaning it should be tailored to your abilities. You should always tell the study team if you're experiencing fatigue or discomfort.

How to find out more

Marie-Eve Rougé-Bugat, MD

marieeve.rouge-bugat@dumg-toulouse.fr 5 61 80 01 23 Official trial record

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