How do you talk to patients about clinical trials?

I try to incorporate the clinical trial idea into the standard of care recommendation/discussion at the time of initial treatment decision making. After making a standard of care rx recommendation, I tell patients that my recommendation is based upon this treatment being the winner of a prior trial comparing this current treatment to the prior standard of care treatment. For randomized trials, I then present the trial of interest and explain we are attempting to evaluate a potentially but unproven further improvement to this standard of care. I find it harder for a patient to abandon an already accepted and discussed treatment for clinical trial involvement if the two discussions are temporally separated. I mention the common motivations for trial involvement including a potential better treatment, the attention to details in a clinical trial and finally how some patients express altruism in joining a trial. For the best success rate, the physician should bring up the trial participation concept. Lou Fehrenbacher

I tend to express clinical trials as a normal part of discussion. Using the same skills as in discussing hospice, I utilize the ASK-TELL-ASK or SPIKES model.  

During my interview, I ask (Ask of ASK-TELL-ASK or P of SPIKES) patients what they know about their cancer, their treatment options, their concerns/worries and their hopes. This helps me define their potential boundary of knowledge, experience and expectations. If the reality is somewhere outside of it, I ask them in various ways (I will focus on trials here).

- normalization: "Many patients wonder about clinical trials..." or "many patients have questions about [whatever the newest buzz words is]..."... "do you have those questions?"  

- explore: "Have you heard of clinical trials? What do you know about them?"

I typically listen without commenting on it (do not engage in conversation at that time). Even if they say things like—I don't want to be a guinea pig. Acknowledge them by saying something like "I appreciate you sharing this with me."

Typically, either in the beginning of the interview or during history, I have asked both patient and caregiver about what their questions are and have told them that I will address them today, but not necessarily right at that moment.  

Once I have done my evaluation (completed history, exam and review of studies), I will start by framing what we know. I say to them: there are four questions I must answer for every patient.  

- What is the cancer, or diagnosis?

- where is the cancer, or staging?

- what does it mean to "me" or prognosis?

- what do we do about it—what are the treatment options?  

I editorialize with the comment that most patients and caregivers questions are on the #4; but I can't answer that until I have answered the first three, at least to myself. 

Then as we talk about the treatment options, I tell them:

"When it comes to treatment options, I divide them into two, what we consider standard of care, and what we consider experimental or trial."

If they had expressed any specific concerns about trials, I would address them here. I would NOT minimize them, if they felt they didn't want to be a guinea pig, I would ask them what that meant. What is the story behind that comment, "did they know anyone on trial?"; "was it based on some past experience or even things like the Tuskegee airmen trial?"  

Many have concerns about "placebo." I encourage them to explain what the concern is and tell them as their doctor, my focus in on doing the best for them and I would never prescribe "just a placebo".  Then I would ask for their permission to explain (to ensure that they will actually listen)...and tell them that typically patients on trials that have placebo also have standard of care with it; so they are at the minimum receiving standard of care.  

I also discuss the standard of care. I have not yet figured out whether SOC or clinical trials should be discussed first. But that usually is driven by how the conversation is going.  

I do have trials in first line and in settings where there is NO SOC, so I do tell them the rationale. Most times the phrase "today's SOC was yesterday's clinical trial" comes up.   

I do disclose my bias, I tell them that being at a cancer center, I am more likely to discuss trials than non-academic settings (been there as well). I also tell them I am PI on some and investigator on others.  

If they ask, I will tell them that it is a quality indicator for my job performance and center and cancer program's (COC) performance. Although, not many have questioned my motivations (whether it's financial etc). For those here focused on communication skills, this is essentially about how to have patients hear what you have to say. It's about addressing the emotions first. It is NOT about science, rather about emotions. This is SPIKES!

Some additional thoughts relevant to clinical trials in the multi-modality, curative intent, initial management setting:

1. It is unbelievably helpful if the patient and family hear the same message about best standard option, best clinical trial option, and why the clinical trial seems like the better choice for them (when it does). This happens most readily in multi-modality clinics.

2. Patients may assume that "standard of care treatments" are great treatments, much the way standard of care is great treatment for many non-life threatening, non-oncologic problems: low risk profile and very high probability of satisfactory and durable success. Re-framing the realities both about risk and benefit is often a necessary and challenging part of making the case for a clinical trial.

3. The official consent forms are extremely difficult documents and need to be put in context. After awhile (years of practicing), I found the following analogy to be useful (this was pre-corona virus pandemic): "Imagine what a similar document would read like if you had to sign a government mandated consent form every time you took a commercial flight run by one of the usual major airlines. Here is a partial list of what such a document would include: Chance of delay, chance of delay on the tarmac without access to bathroom, chance of flight being cancelled, chance of risk to life for severe bodily harm from crashing, turbulence. Chance of failing to reach your destination including crash, diversion to a different airport, returning to original airport. Chance of being annoyed by people sitting near you - noise, smells, behaviors. Chance that the flight attendant will spill something on you, be rude, or have you thrown off the flight. The airplane may be dirty, too hot, or too cold. Chance of experiencing a major medical crisis unrelated to the flight itself- heart attack, abdominal crisis, etc. Chance that after the flight a person might develop a DVT or pulmonary embolus. Chance of bathroom failure to function, etc....."

I'll bet right now your are thinking of other things that could be added to this list. Using this analogy often helped patients and families understand what the official IRB approved informed consent document was seeking to accomplish.

4. Physicians are increasingly under pressure to increase patient throughput and this clearly conflicts with taking the time required to answer all of the relevant questions that deserve answers given in a careful, thoughtful, and respectful manner. Having the physician prepare the patient to have an open mind about a clinical trial followed by letting the research nurse go over the trial and consent and answer questions in a different session, seemed to work best for us.

5. Finally, I found that only one in three to one in five patients were willing to accept a clinical trial. It's a tough, time consuming process to get patients enrolled. It requires a lot of commitment and a lot of willingness to keep trying in spite of how often you hear "no thank you".

I discuss clinical trials as a potential treatment option after discussing a standard of care option. For some patients, standard of care isn’t an option. Usually in the first line setting, a trial drug (or placebo) is given in conjunction with standard of care, so the main downside is increased toxicity and, rarely, decreased efficacy. I see clinical trials as a mechanism for our patients to get the novel drugs before they are approved. Also, many of my patients are happy to hear that they can potentially help other patients by participating in a trial. 

For patients in the metastatic settings where standard of care is approved and we have ample data of its efficacy and potential toxicity, I would definitely be in favor of delivering SOC first, and I will mention then that when/if this first line therapy fails, we have many other potential drugs in the phase of development. This will motivate patients to participate in therapy and give them hope, cautiously. 

If I get a referral from my conventional colleagues, then the discussion is different. 

In this case, we are talking to a patient who had progressed on the available effective therapies. Those patients have lost hope and coming to our office are seeking a life saving therapy with a trial drug that is in phase I of development. 

I will first explain the disease prognosis and natural history without any intervention. 

Then I will explain the logistics of clinical trials, in particular phase I, and what to expect. 

Depending on where the trial is, and in pre-clinical studies, I will touch on what to expect in terms of toxicities and how we will handle them, depending on the mechanism of action of the investigational product(s). 

I will spend time to answer many questions, many of them are existential in nature, and others are related to the cost and toxicity of the drug. 

With clinical trials, legally, we need to hand out our patients paperwork for at least 24 hours to review. 

During the second interview, I will consolidate further questions and help patients make a decision that is in their best interest.