I feel like a hostage to the clinical trial. - 1247518

trux4
Posts:1

My NSCLC ALK+ husband had 2 good years Stable Disease on Crizotinib when a new tumor (<0.5 cm) appeared in CT, then 12 weeks later was >1 cm and thus Disease Progression. When new tumor first appeared, radiologist recommended further evaluation but doctor said it would not be helpful and extended the scan interval from 6 weeks to 12 weeks. After new tumor was >1 cm, I asked for a PET scan, but doctor again said it would not be helpful. We looked for new clinical trial. Attempted rebiopsy was unsuccessful at obtaining useful sample.

Now, we are approaching 12 week point on Chugai AF802. First 6 week CT scan was stable.

I am grateful that the hospital expedited their enrollment in the AF802 study for my husband's benefit, but we are stuck with this same doctor again. (This is the same doctor that made us wait 7 days to get CT results for every 6 week scan, for a year. After a year of that horrible scanxiety, he finally agreed to let the nurse call us with the results if they continued to be stable.)

I don't think the doctor's first loyalty is to my husband so I won't even go to the checkups with him anymore for fear I'll be rude and embarrass my husband. I feel like a hostage to the clinical trial.

What can I do when I don't trust the doctor but it looks like the only avenue to my loved one's lifeline?

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Dr West
Posts: 4735

The trial is really done by a rather fixed protocol, meant to have straightforward rules that lead to the same practice being done everywhere the study is offered. This means that, for better or for worse, there isn't really much room for "style" or judgment compared with how we can manage patients outside of a trial. I guess the up side of this is that even if you don't connect well with the doctor, you can at least know that the treatment being given is "by the book", according to the protocol's guidelines.

My only real suggestion in terms of potentially making a better connection is that if you can talk to someone else affiliated with the study, perhaps a study nurse or other person you've worked with at the same center, you might be able to ask if it's possible to have your husband's care be taken over by another person at the same center who can oversee his care on the same protocol. That might just be possible.

-Dr. West

hopey5000
Posts: 24

I can appreciate your desire for some element of control, but the first trial had good results, and this is a promising drug. The initial phase 1 study showed promising results and your spouse also benefited. "Conclusions: CH5424802 was well tolerated with promising efficacy in pts with ALK-positive NSCLC. 2012 ASCO Annual Meeting, Abstract No:7602

As you realize, this is a study with defined parameters and procedures. Other than reporting study results after a week, I am not sure what the doctor did wrong. He may not be a touchy feely doctor, but he is apparently a skilled researcher who may make a substantial impact in improving people's lives.

There is my sense that being too assertive could jeopardize your participation and I am not sure for what purpose. i can see more downside with your trying an end-around this doctor who I would assume has substantial authority of the trial and protocol

Perhaps you could separately retain another oncologist to answer your questions and concerns, with the proviso, that this person will not interfere or call about the study, but just be there to answer your questions and give you and idea of what's going on. Perhaps though, another doctor would not want to take on that strange role. . So my advice, look at the big picture, a good initial result and some promise now, rather than seeking to vindicate your desire for control.

blue skies
Posts: 69

Oncologists have many talents. And some of the really talented ones may not have the remarkable people skills that we see in Dr. West and Dr Weiss and the others who so generously invest their time in this website.

But, as Dr. West points out, there is a TEAM of people supporting this study and monitoring patient care, including research fellows, the "research nurse(s), and probably a fair number of "clinical" nurses. I am betting that there is someone in this group who can be the "softer" side of this clinical trial experience.and who will know how to query the oncologist on your behalf and be your intermediary. I'll bet by now that you have identified someone you've seen in action or interacted with in person or by phone who looks like they could be a good candidate for that role. I suggest that you find a way to reach out to that person "to ask their advice" and see where that conversation goes.

A good time might be when you have your initial conversation with someone at your next appointment where they ask you, "How are you doing? Any symptoms to note?" At the end of that conversation, you might add, "I have a concern about...." and pick something easy like the "call me with the scan results" problem (to make sure the nurses know it is an issue for you and will make sure they follow up. Perhaps follow with "I know the doctor is really pressed for time. It would be really helpful if I had someone I could reach out to to ask questions of. " Or, make a call on a non-clinic day (when the team is not so "busy" dealing with a slew of patients on the study?

I am pretty sure you are not the only patient that feels this way and it won't be a surprise to the people who work on this team. They will likely have some strategies to help. And you will feel better just for asking the question and expressing your pent up feelings.

Good luck. Let us know if you find your angel in the practice!