Everyone wants the latest and greatest when it comes to phones, cars, and cancer treatments.
Okay, maybe that last one doesn’t come to mind right away. But for someone living with cancer, making sure they have the most cutting-edge medical treatment is vital.
Clinical trials are undertaken by medical researchers across the world and may offer more cutting edge treatment options. These trials are often being done to find the optimal type of therapy to improve success and/or reduce side effects compared to the current standard of care therapy. As you learn about a new clinical trial, come prepared with these must-ask questions for your oncologist.
1. Why are you recommending this trial (aka Why Me)?
Your doctor may suggest a clinical trial for a variety of reasons, and it is important to understand whether and how this trial might help you specifically. Sometimes, clinical trials are being done to collect information that could impact future patients but may not have a direct impact on your care.
2. What’s “new” in this trial?
With any clinical trial, something “new” is being done, and so there are always going to be unknowns. But it will be helpful to understand what the “new” thing is for a trial. Does the trial involve a new, investigational treatment, or is it looking at a new way of delivering or combining old, established treatments?
3. What will I be doing if I am part of this clinical trial?
How will the therapy be delivered? Maybe you will be asked to take a pill at home every day or maybe you will need to make visits to an outpatient clinic for infusion therapy or even have to be admitted to the hospital for treatment.
How long will the trial last? If you’ll be visiting an infusion center, how long will each visit take? How many times each week or each month will you need to come in for treatment?
Will there be extra visits to the doctor or clinic/hospital required? A trial may involve more frequently getting your blood taken, additional imaging scans, or even undergoing extra biopsies or procedures. Are they flexible to accommodate your schedule if you have a family or work commitment?
4. What side effects should I expect from the treatment?
This is a pretty natural question once you understand what the treatment will be like, and it might be the largest one hanging over your head. Will you lose your hair or be nauseated? Will you be able to continue doing work or driving?
When you consider a clinical trial, you’ll be handed a massive packet of consent paperwork, reminiscent of an ancient Yellow Pages book. It will include a whole section about side effects, ranging from the expected and predictable to the gruesome and unimaginable.
It’s important to ask your oncologist to specify which side effects have so far been observed more commonly in patients on this trial. Perhaps there’s a group of other people that have already been through this protocol, locally or at another medical center; what have people been seeing in patients who are on this trial elsewhere?
It is also important to understand how you will be monitored for side effects and who to contact if you develop a new or concerning side effect at home.
5. What “phase” is this trial?
Perhaps your oncologist mentioned “a phase 2 clinical trial combining X and Y immunotherapy drugs,” and the thought of becoming a lab test rat is racing through your mind. But it’s important to make the distinction that even if a clinical trial is “phase 1” doesn’t mean it is dangerous, scary, or something to eliminate entirely.
Before a clinical trial even makes it to patients, significant time has already been invested in what are called “pre-clinical studies.'' Cancer treatment lab testing involves researchers analyzing tumor cells in a petri dish or test tube or in animals to determine the activity of a treatment. In the United States, approval from the Federal Drug Administration (FDA) is still required for pre-clinical studies to become first-in-human, phase 1 clinical trials. (If you are considering a clinical trial in another country, it is crucial you understand how trials are regulated there as it may not be as rigorous a system as what we have in the U.S.)
A phase 1 trial is done to evaluate safety, determine safe dosing, and/or identify side effects. A phase 2 trial is then done to see whether the drug or intervention is actually effective while continuing to learn more about its safety. A phase 3 trial is where the efficacy of a treatment is put to the test and compared to other treatments to see which is a superior treatment when considering both the benefit and the side effects.
6. What are my treatment options if I don’t go on this trial? Am I eligible for any other trials?
This one is pretty self explanatory. Make sure you understand the alternatives to enrollment on this trial, including availability of other trials with your doctor or even at another institution.
7. Who are the members of the research team, and who will I be working with directly?
When enrolling in a clinical trial, your doctor is only one member of a larger care team. A clinical research coordinator often works alongside the doctors to ensure the protocol is adhered to. There may be other nursing staff assigned to the team. You may also be given a “triage nurse line” to reach an on-call nurse, 24/7, to discuss reactions, side effects, or other urgent concerns. It’s important to get this information upfront so you feel prepared to handle situations that arise during your clinical trial process.
Final thoughts
This whole process may feel overwhelming, but asking these clarifying questions will bring you peace. Knowledge is power, and harnessing that power will help ease your worries. You can’t control how cancer grows or the rigid clinical trial protocols, but you can control the information you have and how it makes you feel.
“Having a positive attitude” is very general advice given during difficult situations, and undergoing new cancer treatments is no exception. Attain your own positivity by becoming fully aware of what to expect from this clinical trial process. With confidence and knowledge comes strength and healing. When you have cancer and you’re undergoing a clinical trial, you deserve that.
Please note this article is purely informational and not intended to be medical advice. All decisions regarding your personal medical care should be discussed with your treating physician or oncologist.
