RecruitingNAINTERVENTIONAL

Evidence Development in Cancer Treatment - Real World: PREDiCTrw

This study, called PREDiCTrw, is for people with cancer. It aims to understand how new cancer treatments, which show some promise but haven't been fully proven in large trials, affect patients' quality of life and how long they live. Instead of a traditional trial, we're looking at real-world information. Doctors often use early findings to guide treatment, but it can be hard to know for sure how much these new treatments truly help, how they affect daily life, and if they are good value for money. By collecting information like how patients feel and how their cancer responds, this study helps build a clearer picture to support important decisions about cancer care.

At a glance

Status

Recruiting

Phase

Sponsor

British Columbia Cancer Agency

Enrolment target

100

Start

22 Jan 2024

Estimated completion

01 Jan 2029

Cancer

What is this study about?

When new medicines for cancer are discovered, they first go through very strict studies. Sometimes, these studies show that a treatment is promising, but we don't yet fully understand how much it will help people in their everyday lives, or how it compares to other options. This particular study, named 'PREDiCTrw', aims to fill in some of these gaps. It's designed to gather information from people with cancer who are already receiving these newer treatments in a real-world setting, rather than in a highly controlled research environment. This helps us see how these treatments truly work for a broader range of patients.

The main goal is to understand two key things: how the treatment affects a patient's 'quality of life' (meaning how well they feel, their ability to do daily activities, and overall well-being) and how long they live. Doctors often look at early signs like whether a tumour shrinks, but it's also important to understand the bigger picture of how a treatment impacts someone's life. By collecting this 'real-world' information, the study aims to give doctors and healthcare decision-makers a clearer idea of the true benefits and potential costs of these treatments.

Ultimately, this study helps us to make better decisions about which cancer treatments are most helpful, not just in terms of fighting the cancer, but also in supporting a good quality of life for patients. This kind of information is crucial for ensuring that people have access to the most effective and appropriate care possible. It's about using everyday healthcare experiences to learn and improve future treatments.

Key takeaways

The study helps us understand how cancer treatments work in real life.
It focuses on your quality of life and treatment outcomes.
You won't receive new experimental drugs; it observes your existing care.
Your input through questionnaires is very important.
The information gathered helps doctors make better decisions for all patients.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to have a cancer for which there are still some unknowns about how effective a particular treatment is, or how cost-effective it might be. Generally, you should be well enough to carry out most of your daily activities, meaning your doctor thinks you are fit enough to manage the treatment. You would also need to be expected to live for at least another 12 weeks according to your doctor, and your blood tests and organ functions (like kidney and liver) should be good enough for the treatment.

There are also some requirements regarding contraception. If you are a woman who could become pregnant, or a man whose partner could become pregnant, you would need to agree to use effective birth control during and for at least 5 months after the treatment. This is to ensure no pregnancies occur during the study. You must also be able to understand and agree to take part in the study.

However, you would not be able to join if you have been involved in another drug study or received another new treatment within the last 14 days. If you find it difficult to fill in questionnaires about your quality of life, or if you are pregnant or breastfeeding, the study won't be suitable. Also, if you have certain serious health problems, such as significant heart disease, a recent major infection, or if you've had major surgery recently (within 21 days), and your doctor feels it would make the treatment unsafe, then you would not be able to participate.

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 for which a treatment's full benefits are still being explored?
Am I generally well enough to go about most of my daily activities?
Have I avoided other experimental treatments or studies in the last 14 days?
Am I able to fill out questionnaires about how I feel?
Am I not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with your regular cancer treatment as prescribed by your doctor. The study itself won't involve taking new experimental drugs. Instead, it focuses on collecting information about your health and how you are feeling during your treatment.

You would have regular appointments, likely including scans (like X-rays or CT scans) and blood tests, to check on your cancer and overall health. A very important part of participating is filling out questionnaires about your 'quality of life'. These questionnaires will ask you about things like how you're feeling, your energy levels, and your ability to do daily tasks. You would fill these out regularly throughout your treatment. The study aims to gather this real-world information to help understand the actual effects of your treatment. The total duration of your participation would depend on your course of treatment and how long you are followed up, but it would align with your ongoing care.

Potential risks and benefits

The main benefit of taking part in this study is that the information collected from your experience will help improve understanding of certain cancer treatments. This can contribute to better decisions for future patients and potentially help ensure access to effective care. As this study observes your routine treatment, it doesn't involve new experimental drugs, so the risks directly from the study procedures (like questionnaires) are very low. However, you will still experience any potential side effects or risks associated with the standard cancer treatment you are receiving, which your doctor will discuss with you. Remember, joining any study is completely voluntary, and you have the right to withdraw at any time without it affecting your ongoing medical care.

Locations (1)

BC Cancer
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is 'real-world' information?

It means collecting details about how people respond to their treatments in their everyday lives, outside of highly controlled study environments.

Will I receive a new treatment in this study?

No, this study observes the treatment you are already receiving; it does not involve giving you new experimental drugs.

What is 'quality of life' in this study?

It refers to how you feel, your ability to do daily activities, and your overall well-being, which you'll report through questionnaires.

How long will I be involved in the study?

Your involvement depends on your treatment plan and follow-up, aligning with your regular medical care.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and it will not affect your medical care.

How to find out more

Cheryl Ho, MD

cho@bccancer.bc.ca 604 877 6000 Official trial record

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