RecruitingOBSERVATIONAL

Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma:

This research is looking into an important question for people diagnosed with certain blood cancers, Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), who don't have symptoms yet but are considered high-risk. Doctors want to understand whether it's better, both for health and economic reasons, to start treatment right away or to wait until symptoms appear. The study will track healthcare use, productivity at work, and how people feel about their health over a long period. The goal is to figure out which approach offers the best balance for patients and the healthcare system. It's a key step in helping doctors make the most informed decisions for future patients.

At a glance

Status

Recruiting

Sponsor

Canadian Cancer Trials Group

Enrolment target

247

Start

27 Jan 2023

Estimated completion

01 Oct 2028

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

What is this study about?

This study is designed for individuals recently diagnosed with a type of blood cancer called Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). These conditions are closely related. Importantly, this study focuses on patients who haven't yet developed any symptoms, but are considered to be at a higher risk of their disease progressing.

The main aim of this research is to compare two approaches: starting cancer treatment right away versus waiting until symptoms develop. Doctors want to understand not only the health outcomes of these two strategies but also the economic impact. This means looking at things like how much healthcare resources are used (hospital visits, scans, tests), how the different approaches affect a person's work productivity, and their overall quality of life. By collecting this information over a long period, researchers hope to gain a clearer picture of which strategy is most beneficial for patients and the healthcare system in the long run.

To gather this information, participants will be asked to complete questionnaires about their health and daily activities. Researchers will also keep track of all healthcare services used as part of their treatment, like clinic visits, lab tests, and any hospital stays. The results of this study will help healthcare professionals make better decisions when advising future patients with CLL or SLL on the best time to start their treatment.

Key takeaways

This study compares starting CLL/SLL treatment early versus waiting.
It focuses on patients who don't have symptoms but are high-risk.
Researchers will track health, healthcare use, and quality of life.
Information will be collected over a long period (up to 10 years).
Participation involves completing questionnaires and regular health checks.
The goal is to improve future treatment decisions for CLL/SLL patients.

Who may be eligible?

To join this study, you need to be eligible for the main cancer trial it's part of (called CLC3/S1925). You must also agree to take part by signing a consent form after understanding everything about the study.

It's important that you can understand and fill out health questionnaires in either English or French. You'll need to complete these questionnaires at the beginning of the study, before you officially join. Don't worry if you find it hard to complete forms due to language barriers or thinking difficulties, as this won't stop you from joining. However, if you are able to complete the forms but simply don't want to, then you wouldn't be able to join.

Finally, you need to be available for all your appointments and follow-up checks so that the study team can keep a full record of your health, any side effects, and how your treatment is going. This study is open to both men and women aged 18 years and older, with no upper age limit.

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.

Am I already eligible for the main cancer study (CLC3/S1925)?
Am I willing to sign a consent form to participate?
Can I understand and complete health surveys in English or French?
Am I willing to complete the initial health questionnaires on time?
Am I able to attend all necessary appointments and follow-up checks?
Am I 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the research team will collect information about your health and healthcare use from the moment you join. This will continue for up to 10 years, unless you pass away or leave the study early.

Your participation will involve regular visits for examinations, scans (like X-rays or CT scans), blood tests, and receiving your treatment (if you are in the group that starts treatment early). The study team will track all these activities. On top of this, you will be asked to fill out two types of questionnaires. One will ask about your general health and how it affects your daily life (EQ-5D-5L). The other will focus on your work productivity and any daily activities that might be impacted (WPAI survey). You will also complete a special form (SMRC) to help document any healthcare visits or stays that aren't part of the regular study plan, such as emergency room visits or hospital admissions.

Potential risks and benefits

Participating in research always carries potential benefits and risks. A potential benefit of this study is that it will help us learn more about the best timing for treatment for CLL/SLL, which could improve care for future patients. For you personally, by closely monitoring your health, any changes could be detected early. As for risks, you might find the questionnaires time-consuming, and there will be regular study visits which could add to your schedule. However, all medical care will be provided by your regular treatment team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

BCCA - Vancouver
Verified postcode
Vancouver, Canada· Recruiting
CancerCare Manitoba
Verified postcode
Winnipeg, Canada· Recruiting
Regional Health Authority B, Zone 2
Verified postcode
Saint John, Canada· Recruiting
QEII Health Sciences Centre
Verified postcode
Halifax, Canada· Recruiting
Lakeridge Health Oshawa
Verified postcode
Oshawa, Canada· Not yet recruiting
Ottawa Hospital Research Institute
Verified postcode
Ottawa, Canada· Recruiting
The Jewish General Hospital
Verified postcode
Montreal, Canada· Recruiting
Allan Blair Cancer Centre
Verified postcode
Regina, Canada· Recruiting

Common questions

What kind of cancer is CLL/SLL?

CLL and SLL are types of blood cancer that affect white blood cells called lymphocytes.

What does 'asymptomatic' mean?

It means you don't currently have any noticeable symptoms of your cancer.

What does 'high-risk' mean in this study?

It means your medical team believes your cancer has a higher chance of progressing or needing treatment sooner, even if you don't have symptoms yet.

Will taking part affect my regular medical care?

No, your regular medical care will not be affected. You will continue to be treated by your usual healthcare team.

How long will I be in the study?

Information will be collected for up to 10 years, or until you leave the study or pass away.

How to find out more

Annette Hay

ahay@ctg.queensu.ca 613-533-6430 Official trial record

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