Active not recruitingNAINTERVENTIONAL

Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life

This study aims to understand how doctors manage bone cancer that has spread from other parts of the body, especially when patients have been receiving injected medicines (like bisphosphonates or denosumab) for at least 12 months. We want to see how current treatment choices – whether continuing injections, switching to daily pills, or stopping treatment – affect a person's quality of life. We'll also look at how safe these treatments are, how long people live, and how side effects impact their well-being. Ultimately, this research will help improve care for people living with bone metastases.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

148

Start

14 Jun 2016

Estimated completion

31 Jan 2025

Tumor With Bone Metastasis

What is this study about?

This study is designed to understand the current ways doctors treat people whose cancer has spread to their bones. Specifically, it's looking at patients who have been receiving special medicines, given by injection, for at least a year. These medicines, often called bone anti-resorptive treatments, help strengthen bones and prevent them from breaking.

The main goal of this research is to see how these treatments, and the decisions doctors make about them (like whether to continue injections, switch to daily pills, or stop treatment altogether), affect a patient's overall quality of life. This means looking at how people feel day-to-day, their physical well-being, and their ability to do regular activities. We want to know if current practices are helping people live as well as possible.

Beyond exploring quality of life, the study also plans to look at other important details. This includes how safe the treatments are, how long people live, how any side effects might impact their well-being, and the types of support care patients receive. The information gathered will help doctors make better decisions and improve the care for people with cancer that has spread to their bones, helping them to live more comfortably.

Key takeaways

Study focuses on cancer that has spread to bones.
Investigates current injectable bone treatments (given for 1+ year).
Main goal is to understand how treatments affect patients' quality of life.
No new treatments or extra appointments are involved.
Helps improve care for future patients with bone metastases.
Participation involves answering questions about your well-being.

Who may be eligible?

To join this study, you would need to meet certain conditions. First, you must have cancer that has been confirmed by a doctor, and this cancer must have spread to your bones. This can be to one bone or several bones, and you might also have cancer in other parts of your body.

Another important requirement is that you must have been treated with a specific type of bone-strengthening medicine, given as an injection, for at least the past year. Also, to make sure you understand what you're agreeing to, you'll need to give your signed permission to take part.

There are also some reasons why you wouldn't be able to join. For example, if you have any medical or mental health condition that would make it very difficult for you to answer questions about your quality of life, you wouldn't be able to participate. Also, if you are under legal guardianship, curator, or protection of justice, or if you are pregnant or breastfeeding, this study would not be suitable for 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.

Do I have cancer that has spread to my bones?
Have I been getting bone-strengthening injections for at least 12 months?
Am I able to comfortably answer questions about my daily life and feelings?
Am I over 18 years old?
Am I able to provide my signed consent to take part?

Answer every question to see your result.

What does participation involve?

This study does not involve new medicines or treatments. Instead, it observes and collects information on the treatments you are already receiving as part of your standard medical care. You will be asked to complete questionnaires about your quality of life, which means how you are feeling and how your condition and treatment are affecting your daily life. The study will also collect information from your medical records about your treatment, any side effects, and your overall health. There are no extra hospital visits required beyond your usual appointments. The total duration of your participation would depend on how long you are followed up as part of your regular care, but the focus is on gathering data from previous and ongoing treatments.

Potential risks and benefits

Taking part in this study may not directly benefit you, as it focuses on gathering information rather than providing a new treatment. However, the information collected will help doctors better understand how current treatments affect patients and could lead to improved care for others in the future. There are no new medical risks involved, as you will continue with your standard care. The main commitment would be the time taken to complete questionnaires. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (2)

Centre Hospitalier Régional Universitaire de Besançon
Verified postcode
Besançon, France
Hôpital Nord Franche-Comté
Verified postcode
Montbéliard, France

Common questions

What kind of treatments are being looked at?

The study is looking at injectable bone-strengthening medicines like bisphosphonates or denosumab, which you've been taking for at least a year.

Will I get new medicine in this study?

No, this study doesn't give you new medicines. It observes the treatments you're already receiving as part of your normal care.

What does 'quality of life' mean in this study?

'Quality of life' refers to how your health and treatment affect your daily activities, feelings, and general well-being.

Do I have to go to extra appointments for this study?

No, this study doesn't require extra hospital visits. Information will be collected during your usual medical appointments and through questionnaires.

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.