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Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)

This study focuses on understanding the quality of life for people with anal cancer who are treated with a combination of chemotherapy and radiotherapy, known as chemoradiation. It's an observational study, meaning researchers will carefully watch and record information without giving new treatments. They'll use special questionnaires to see how patients' daily lives are affected. They'll also check how well the treatment works, if there are any side effects (both immediate and long-term), and how the body's functions are doing. The main goal is to get a full picture of the patient experience and treatment outcomes for this type of cancer.

At a glance

Status
Recruiting
Sponsor
Ludwig-Maximilians - University of Munich
Enrolment target
100
Start
01 Dec 2018
Estimated completion
01 Dec 2026

What is this study about?

This study, called LANACARE, is designed to understand what life is like for people who have anal cancer and are being treated with a combination of chemotherapy and radiotherapy (often shortened to chemoradiation). This combined treatment is a common way to deal with anal cancer without needing surgery to remove the affected area.

The researchers want to see how patients' quality of life changes over time after this treatment. This isn't a study where new drugs are being tested; instead, it's an "observational" study. This means the doctors and researchers will simply be observing and collecting information from patients who are already receiving this standard treatment. They'll use special questionnaires recognized throughout Europe to ask about various aspects of daily life, such as physical well-being, emotional health, and social activities.

Beyond quality of life, the study will also look at how well the treatment works to control the cancer, any side effects that occur (both soon after treatment and much later), and how different body functions are affected. By gathering all this information, researchers hope to get a better understanding of the overall journey for people with anal cancer undergoing chemoradiation. This knowledge can then help improve care and support for future patients.

Key takeaways

  • This study observes people with anal cancer undergoing standard chemoradiation.
  • It aims to understand long-term quality of life and treatment side effects.
  • No new treatments are given; you receive your usual care.
  • Participation involves completing questionnaires about your well-being.
  • The findings could help improve care for future patients with anal cancer.

Who may be eligible?

To be able to take part in this study, you must have anal cancer that has been confirmed by a small tissue sample, and your cancer must not have spread to other distant parts of your body. Your healthcare team must have decided that chemoradiation is the best treatment for you.

You also need to be at least 18 years old and be able to understand and sign a consent form. It's important that you can also fill out the questionnaires asked of you by the study team.

You cannot take part if you are under 18, have already had chemotherapy for your anal cancer, if the cancer has spread to distant parts of your body, or if you have another type of cancer.

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. Do I have anal cancer that has not spread to distant parts of my body?
  2. Have my doctors recommended chemoradiation as my treatment?
  3. Am I 18 years old or older?
  4. Am I able to fill out questionnaires about my health and life?
  5. Have I not had chemotherapy for anal cancer before?
  6. Do I not have any other type of cancer?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't receive any new medication or treatment. You will simply be observed and asked questions as you go through your standard chemoradiation treatment for anal cancer. You will fill out special questionnaires about your quality of life at different points during and after your treatment. Your doctors will also keep track of your treatment's effectiveness, any side effects you experience (both short-term and long-term), and how your body is functioning. The exact number of visits or the total length of your participation will depend on your hospital's standard follow-up schedule after chemoradiation.

Potential risks and benefits

Participating in this study might help improve understanding of what it's like for people with anal cancer undergoing standard chemoradiation. This could lead to better support for future patients. There are no new medical risks as you will be receiving your usual care. The main commitment is your time to complete questionnaires. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

  • Department of Radiation Oncology, University Hospital, LMU Munich
    Verified postcode
    Munich, Germany· Recruiting

Common questions

What is chemoradiation?

Chemoradiation is a common treatment for anal cancer that combines chemotherapy drugs with radiotherapy (high-energy rays) to target and kill cancer cells.

Will I get different treatment if I join this study?

No, you will receive the standard chemoradiation treatment that your doctors have already planned for you. The study simply observes your journey with this treatment.

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

It means how your daily life, feelings, and physical health are affected by your cancer and its treatment. The study uses questionnaires to understand this.

How long will I be involved in the study?

Your involvement will follow your normal check-up schedule after chemoradiation. You'll fill out questionnaires at various points during this time.

Is my information confidential?

Yes, all your personal and medical information will be kept private and anonymised as much as possible to protect your identity.

How to find out more

Falk Roeder, MD

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 "Prospective Observational Trial to Evaluate Quality of Life …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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