Clinical trials and how to include them in treatment planning

Carefully chosen appropriate clinical trials are a great way to expand treatment options. But it’s easier said than done. How do patients start to learn more about trials so they can get better at choosing the ones most appropriate for them?

1. Start looking for trials early in the cancer journey. Now that you know standard of care—the treatment that any oncologist can provide you—are limited and the dismal 5 y survival rates, and you have some idea of your goals of care, you can start learning about trials. Anything and everything you learn will be helpful. Just like learning a new language, everything is gibberish in the beginning, but over time, things will start to make sense. What you don’t have is time–decisions need to be made quick and fast and under stressful conditions. So, start early. Immediately after the diagnosis, it takes time for things to sink in and for you to get your footage back after the turmoil of the initial days after the diagnosis, and start of treatments etc. When you have had the 3rd or 4th round(cycle) of chemo and know what to expect and you have a new routine in place, this is the perfect time to put aside some time daily to learn about clinical trials.

    

2.  Read about the common clinical trial myths: If you want to attempt to beat the odds, you need to be creative about how you go through your cancer journey. Start with the myths about cancer clinical trials and how these may be influencing your thoughts about clinical trial participation. You can learn more about clinical trial myths here.

    

3. Think (and talk) about trials often: Every time there is a bump in the road (eg., a progression while on treatment), ask your care team about applicable clinical trials. Communicate with them early about your interest to integrate clinical trials in your journey. At each visit ask “tell me about a clinical trial that can help now”. Don’t settle when you hear “don’t worry, you have many options still available for you” If you hear this, ask that the options be written down on paper for you. Then ask for where all trials can fit in. Save this, take a picture of it on your phone and use this sheet of options every time you meet with the care team and ask them to modify it as needed, as you move through your cancer journey.

    

4. Ask your care team to strategize incorporating trials into your treatment plan early: If you meet with resistance to this whether within you or from your care team, dig a little deeper. Find out the reasons to delay thinking about trials. Consider how things would change if clinical trials were part of the plan. Find out what comes in the way. Find ways to get around things that come in the way. Discuss these with others who are in the same boat as you in communities like the COLONTOWN Clinical trials groups. Strategizing about trials is not easy. Neither is getting treated for metastatic CRC and you are doing it anyways.

    

5. When looking for options, look for things that expand your future options instead of shrink them. For example, will getting this drug now interfere with getting on a trial later? Will not choosing this trial affect your ability to have treatments later? How will this option affect your goals of care? Clinical trials are experimental treatments and if your disease progresses on a trial, will you have standard of care treatment to fall back on which could help with disease control? Is your disease the garden variety slow growing colorectal cancer, or is it a more aggressive type with a BRAFV600E mutation? Does your cancer have targetable mutations with treatments that target the mutations in clinical trials? If that’s the case, could you get on trials that will provide you options that are not available to you as part of standard of care treatments?

    

6. Be aware of all the ways in which your disease can be monitored. When on a clinical trial, it is critical that you know how it’s working for you. The way treatment success is determined is based on radiographic response (response on scans of your tumor) to the treatment. This assessment may be at specific intervals as described in the trial protocol. From your experience living with it, what do you know about how it responds to treatment? Is CEA and CA 19-9 a good marker for you? Are your mets in places that are clearly seen on a CT scan? Do you use a ctDNA test to monitor treatment response? Ideally, the more ways you can follow the tumor, the better it is. This way if an experimental drug is not working for you in a trial, you can decide quickly whether you need to pivot and move to another treatment.

    

7. Decision-making is even more critical as you consider clinical trials: As I mentioned before, decision-making is central to everything on the cancer journey. Decisions around should you continue on this path or take another one? When do you decide it is time to switch to a trial? When do you decide when to get off the trial? Understanding that when we approach decision-making that affects the future, it is always with incomplete knowledge on how things will unfold. No one can predict the future. All we can do is make reasonable and educated guesses based on incomplete information. This is why the quality of that information can greatly affect our decision-making. What maybe best is to have a clear idea of goals of care and periodically check if the goals of care have changed, whether the treatment we receive is continuing to be relevant to our goals of care etc.

    

8. It is important to remember that all of this is a process. Even while you feel that you are overwhelmed with all of it and don’t know where to look etc, it is good to keep things in perspective. Take time to reflect on the enormous challenges you had to face since you were forced into this journey you did not want to be on. You are here trying to learn more about clinical trials and treatments for your disease, while dealing with treatments, all the uncertainties and continuing to live your life. Give yourself some grace. Your understanding of things is dependent on the effort you put in. Even the smallest of effort adds to the learning process. Make sure to appreciate the progress you have made. The amount of things to learn is vast, but you don’t have to learn everything. Learn to prioritize and ask yourself–is this relevant or important to me? Narrow things down to what’s manageable. Is this information relevant to my cancer, the location of my mets, the treatments I am on/ considering, the mutations in my cancer, or the lack of mutations in my cancer, to the surgery/procedure I am considering etc. If it’s not, categorize it as not so relevant. Don’t let the fire-hose of information disorient you. Learning about something is an iterative process. Each time you grasp a little. What you now understand helps you learn other new information you come across. Keep at it and in a bit you won’t feel so lost.

These are a few things to think of as you begin to think of clinical trials. The Clinical Trials Basics section can help answer more questions about clinical trial participation.