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Quality Of Life and Drug Use in Patients With CAR-T Cells

This study is for people with a specific type of lymphoma called diffuse large B-cell lymphoma (DLBCL) who are about to receive a special treatment called CAR-T cell therapy. This treatment, known as Kymriah® and Yescarta®, is a newer option for people whose lymphoma has returned or hasn't responded to other treatments. Because CAR-T cells are very new and costly, this study wants to understand their real-world impact. We'll ask about your quality of life, how you use other medications, and your overall experience with the treatment, helping us get a clearer picture of how it affects patients day-to-day. Your insights are valuable for understanding this important therapy.

At a glance

Status
Recruiting
Sponsor
Hospices Civils de Lyon
Enrolment target
70
Start
31 Mar 2021
Estimated completion
31 Jan 2033

What is this study about?

CAR-T cell therapy is a really innovative medical treatment for people with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL). This therapy is usually given when other treatments haven't worked or when the cancer has come back. It involves taking some of your own immune cells, called T-cells, genetically modifying them in a lab so they are better at finding and killing cancer cells, and then putting them back into your body.

Two specific CAR-T cell therapies, Kymriah® and Yescarta®, have recently become available and are covered by health insurance in France. While they have shown promise in earlier studies, those studies didn't compare them directly to other treatments or look closely at how they affect a patient's daily life. These treatments are also very expensive, costing around £270,000 for a single course, which makes it even more important to understand their full impact.

This study aims to fill those information gaps. We want to understand what it's like for patients receiving CAR-T cell therapy in their everyday lives. We'll be focusing on two main areas: your quality of life – how you feel physically, mentally, and socially – and how you use other medications alongside the CAR-T treatment. We also want to hear your direct experiences and feedback, which will help doctors and healthcare providers better understand the real-world effects of this important and expensive new therapy.

Key takeaways

  • Study looks at real-world effects of CAR-T cell therapy for lymphoma.
  • Focuses on quality of life and medication use.
  • Gathers patient experiences to understand effectiveness and impact.
  • Aims to improve future care for patients receiving this treatment.
  • Participation involves interviews and questionnaires, not changes to your medical treatment.

Who may be eligible?

This study is looking for adults who are 18 years old or older. You must be planned to receive CAR-T cell treatment for diffuse large B-cell lymphoma (DLBCL) at the Hospices Civils de Lyon, and this treatment should be part of your routine care, not within another clinical trial.

It's important that you don't have any major mental health conditions that an investigator thinks would make it difficult for you to take part in the study. You also need to agree to participate by not saying no when asked.

We cannot include people who are living in a care home or similar institution, or those who are under a legal protection order, as this might affect their ability to give informed consent.

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.

  1. Are you 18 years old or older?
  2. Are you due to receive CAR-T cell treatment for DLBCL at Hospices Civils de Lyon?
  3. Is your CAR-T treatment planned as usual care, not part of another trial?
  4. Do you not have any major mental health issues that would prevent you from taking part?
  5. Are you able to provide your consent to participate?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to share your experiences through two main methods. First, you'll have semi-structured interviews. These are like guided conversations where you can talk about your feelings and experiences in your own words. Second, you'll complete questionnaires on your own. These will ask you various questions about your quality of life and the medications you are using. The study aims to gather information over time, reflecting your journey with CAR-T cell treatment. The exact number of interviews or questionnaires and the total duration aren't specified but will be explained in detail if you choose to participate.

Potential risks and benefits

Taking part in this study won't change your medical treatment in any way; you'll receive the same CAR-T cell therapy as planned. The main benefit is helping us understand how this new treatment affects patients' lives, which can improve future care. There are no direct physical risks, but some people might find answering questions about their health and experiences emotionally challenging or time-consuming. You are free to stop participating at any time without giving a reason, and this will not affect your medical care.

Locations (1)

  • Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique
    Verified postcode
    Pierre-Bénite, France· Recruiting

Common questions

What is CAR-T cell therapy?

It's a special treatment where your own immune cells are modified to better fight your cancer.

Why is this study important?

It helps us understand how CAR-T therapy affects patients' daily lives and medication use, especially since it's a new and costly treatment.

Will my treatment change if I take part?

No, your CAR-T cell treatment will remain exactly the same whether you join the study or not.

What will I have to do in the study?

You'll be asked to take part in interviews and fill out questionnaires about your quality of life and medication use.

Can I stop participating if I want to?

Yes, you can withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Catherine RIOUFOL, Pharm. D

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

Interested in taking part?

Register your interest

Share your details and the research team for "Quality Of Life and Drug Use in Patients With CAR-T Cells…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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