RecruitingOBSERVATIONAL

Developing a Patient-Reported Outcome (PRO) Screening Measure for Infections and Measuring Quality of Life in Hematological Patients With Secondary Immunodeficiency (SID) Across the Treatment Trajectory - The PRO SID Project

This study, called 'The PRO SID Project,' is for adults with Chronic Lymphocytic Leukaemia (CLL) or Multiple Myeloma (MM) who have a weakened immune system, making them prone to infections. Researchers want to create an easy-to-use digital tool, like a mobile app, that helps patients report infection symptoms themselves every day. This will help doctors spot infections earlier. The study also tracks how patients' quality of life changes throughout their treatment. The main goals are to see if this new reporting tool works well and to understand how treatments affect patients' daily lives over time. Participants will use the app daily for symptom tracking and complete quality of life surveys less often, with clinic visits every three months.

At a glance

Status

Recruiting

Sponsor

Medical University Innsbruck

Enrolment target

120

Start

03 Feb 2025

Estimated completion

01 Jul 2026

Chronic Lymphocytic Leukaemia (CLL)Multiple Myeloma (MM)Secondary Immunodeficiency (SID)

What is this study about?

This study, called 'The PRO SID Project,' is designed for adults who have been diagnosed with a type of blood cancer called Chronic Lymphocytic Leukaemia (CLL) or Multiple Myeloma (MM). People with these conditions often have a weakened immune system, which doctors call 'secondary immunodeficiency' (SID). This means they are more likely to get infections, and these infections can sometimes be serious.

The main idea behind this study is to find a better way to spot infections early. Researchers are developing a simple, daily questionnaire that patients can fill out on a mobile app. This questionnaire asks about symptoms that might mean an infection is starting. By using this tool, the study hopes to see if patients can help identify infections quickly, potentially leading to earlier treatment. They also want to understand how regular treatments for CLL or MM affect a patient's overall quality of life, using special surveys.

Ultimately, the information gathered from this study could help doctors across the UK and beyond to improve care for patients like you. By developing a reliable way to monitor infection symptoms and understanding how quality of life changes, the study aims to make treatments safer and improve patients' daily experiences.

Key takeaways

It's for adults with CLL or Multiple Myeloma who have a weakened immune system.
The main goal is to create a daily app-based tool to help spot infections early.
It also checks how your quality of life changes during treatment.
Participation involves daily app use and clinic visits every three months.
No new medications are given as part of this study.
The study aims to improve care for future patients.

Who may be eligible?

This study is looking for adults aged 18 or older. To take part, you need to be able to speak German and have access to a device like a smartphone, tablet, or computer with internet access, as you'll be using an app.

You must have a confirmed diagnosis of either Chronic Lymphocytic Leukaemia (CLL) or Multiple Myeloma (MM). A key part of joining is also having what doctors call 'secondary immunodeficiency' (SID). This means your immune system is weakened, which doctors might define as having frequent infections, infections that needed hospital care, low levels of certain immune cells in your blood, or other signs of a weakened immune system.

If you meet these main points, and your doctor thinks it's a good fit, you might be able to participate. It's always best to discuss your individual situation with your doctor.

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 18 years old or older?
Do you have CLL or Multiple Myeloma?
Has your doctor told you that you have a weakened immune system (secondary immunodeficiency)?
Do you speak German?
Do you have regular access to a smartphone, tablet, or computer with internet?
Are you able to use a mobile app daily?

Answer every question to see your result.

What does participation involve?

If you join this study, your main tasks will involve using a mobile app. You will answer short questions about any infection-related symptoms every day. You'll also complete slightly longer questionnaires about your health and quality of life every one and a half months.

In addition to using the app, you will have regular study visits at the clinic every three months. During these visits, the study team will gather important clinical information from your medical records, including details about your ongoing treatments, how your disease is progressing, and any past infections. There's no specific medication given as part of this study; it's about monitoring your health and symptoms. The total duration of your participation will depend on how long your treatment journey is and how long you remain in the study.

Potential risks and benefits

Potential benefits of taking part include contributing to research that could improve how infections are detected and managed for people with CLL or MM, potentially leading to earlier treatment for future patients. You might also find the daily symptom tracking helpful for your own awareness. Possible risks are generally low, mainly involving the time commitment for daily app use and clinic visits, and there's a chance of minor inconvenience from answering questions. There are no new treatments involved in this study, so no new drug-related side effects. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Medizinische Universität Innsbruck
Verified postcode
Innsbruck, Austria· Recruiting
Medizinische Universität Graz
Verified postcode
Graz, Austria· Not yet recruiting
BKH Kufstein
Verified postcode
Kufstein, Austria· Not yet recruiting
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Verified postcode
Berlin, Germany· Not yet recruiting
Klinikum Garmisch-Partenkirchen
Verified postcode
Garmisch-Partenkirchen, Germany· Not yet recruiting

Common questions

What is 'secondary immunodeficiency'?

It means your body's immune system isn't working as well as it should, making you more likely to get infections. This can happen with certain blood cancers like CLL or Multiple Myeloma.

Do I have to take new medication in this study?

No, this study is about monitoring your symptoms and quality of life, not testing new medications. You will continue with your usual treatments as prescribed by your doctor.

What does a 'PRO' tool mean?

PRO stands for 'Patient-Reported Outcome.' It's a way for you, the patient, to directly share how you feel and what symptoms you're experiencing, usually through questionnaires or an app, without a doctor interpreting it first.

How much time will I need to commit?

You'll spend a few minutes each day answering questions on an app and complete longer questionnaires every 1.5 months. You'll also have study visits every three months, which will be part of your regular clinic appointments.

Where is this study taking place?

This particular study is being carried out in hospitals and clinics in Germany and Austria.

How to find out more

Jens Lehmann, Ph.D.

jens.lehmann@i-med.ac.at +43 50 504 81551 Official trial record

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