Situation: you are in the hospital with your child who has just been diagnosed with leukemia. You barely know what leukemia is. Then, the doctors want you to decide whether or not to enter a clinical trial. You barely know what a clinical trial is!
What my husband and I wanted most of all to help us with this decision was to be able to talk to other parents who had already made this decision. Okay, so look out in the hallway: any parents of leukemia children there? Maybe, but, what should I do, shout out: "hey, what about clinical trials?" You can't tell by how parents look what type of cancer their child has. Anyway, they all look like us, pretty terrible, and I really don't want to disturb them.
Ask around, who is there to talk to? Some nice nurses and doctors and orderlies and the lady pushing the snackmobile, but they are no help, they just say, "it's your decision". What about a parents' group? Sure, they often exist, but not at our hospital, and even if they do, they are not hanging out in the in-patient oncology ward.
Therefore: this page. I hope I am able to reach a few parents who are "with it" enough to sign on to a laptop in the hospital and reach this page. The comments are from real parents, parents who were once faced with the same decision.
Please: if you would like your comments included on this page, or if you have more questions, email Patty.
I get to start, since I'm the author :-) We decided to go with the clinical trial. We would have been happy with the standard treatment, and almost took that route. We were quite concerned that our son would get the most intensive treatment, and that it would ruin his senior year of high school. Our son hardly seemed sick at the time of diagnosis, so we had a very strong feeling that he would be cured no matter what we did. But, we were told that he was high risk because of his age, so we felt that perhaps something a little stronger than the standard treatment would be better. Also, I have a strong science background and realize the importance of investigative studies, and this surfaced even in the midst of our post-diagnosis-haze.
We went with the investigative study, and have no regrets.
I'm smiling as I read this post [a request from a newly diagnosed family for information about clinical trials]. Five years ago when we were faced with the same situation, I remember calling Memorial Sloan Kettering from the hospital room and hoping that a nurse wouldn't walk into the room. I had never heard of "protocols", etc. and had to sign the chemo consent form ASAP. I was afraid that the doctors wanted to use my child as a "guinea pig". My first call was to MSK to see if they ever heard of CCG, and of course they certainly had. My next call was to my pediatrician. She was ultimately responsible in our deciding to put our child into the study. I remember the doctor telling me that if it was her child she would put him into the study. So we did choose to participate. We also ended up randomizing into one of the arms of the investigational protocols.
The informed consent form should state that the child's welfare is the most important thing and if the child needs to be removed from the study it is done. Also, the consent form stated that if the parents decide to remove the child from the study it will be done with absolutely no compromised care.
We were in a CCG study, but I don't think POG is much different. The whole basis of the study is to try to find a better treatment for the children. Data is combined from all over the country into a central data bank and the results are compared. The investigational protocols base is that of the standard treatment with something added, increased, or reduced.
An example is when Eric was diagnosed, the standard treatment was induction, consolidation, interim maintenance, delayed intensification and then maintenance, which included IV Vincristine and Prednisone every 4 weeks. Eric randomized to one of the studies, which was identical to the standard treatment, with the exception that he got Vincristine and Prednisone every 3 weeks, opposed to every 4. So for the duration of maintenance, he received about l3 more doses of Vincristine. Another study included 2 delayed intensifications instead of one. But the drugs were identical.
At the end of the study, the results of the 3 different groups were compared and if one of the investigation protocols showed improved survival rates compared to the standard treatment, then the investigational protocol becomes the new standard treatment and they branch off from there.
I know how hard it this is. It's a shame that a decision so important has to be made at the beginning of diagnosis. I'm not sorry that we chose the study for Eric. He did have a lot of side effects from the chemo, but basically I feel that we gave up 3 years of our life for the future. He's now over 2 years off treatment and is doing great!!!
Well, whatever decision that you make, it will be the right one for your child. I wish you the best of luck!!!!!
In the Just-Diagnosed-Haze, I'm sure we were asked to sign the consent form to enter Caedan's CCG 1922 Protocol. For the life of me, I barely remember signing or discussing the "study" with our Nurse Clinician. Even my husband who is a lawyer and signs legal documents every day, doesn't specifically remember understanding the option to consent. That's the kind of shock we were in. I'm very pleased we chose to participate in the Protocol and as I work in a Teaching Hospital affiliated with the University here I try to appreciate the need for research and studies.
Best of luck with whatever decision you make.
It has always been my understanding that clinical trials are the best way to go. You are never getting less than the best available treatment, and you may be getting some small improvement that will increase chances even more. It is never a placebo!!
You really needn't be concerned, although I can understand his apprehension. When Thomas was diagnosed, we were so relieved that he was standard risk that we just wanted the doctors to get him onto a regular, accepted protocol and get it over with. There was no way we were going to have them experiment on him. If his chances were good, then let's leave it that way. We spoke at length with the doctors and researchers and came to the conclusion that their reassurances were valid and that any clinical trials are at least equally as effective as the regular protocol. It is my understanding that many of these trials have been tested before they are implemented on a large scale, and that the chemotherapy used, while it may differ in method or frequency of administration, it does not differ by type.
One thing that is definitely missing from these requests for study participation is patient/parent information and support. In general, I would say that the health professionals are very understanding, but there are so many decisions that parents have to make in the first few days (as your whole life gets thrown into a tailspin temporarily), that I think the parents are not in a position to make the kind of informed decisions that are required of them. I think all of us just thought, make my child better, I don't care/understand what you are talking about, i.e.: POG, etc. It would be nice if the internet hookup in the hospitals could provide parents with info at the time of diagnosis, because I know I didn't go home and hook up after Thomas was diagnosed. I had access to the info the hospitals personnel provided me with.
Quite frankly, there is no choice as to clinical trials. There is not enough of a database to consider the treatment of our children as standard. Just about all pediatric cancer protocols are considered investigational. Look at it this way, there are hundreds of thousands of lung, breast and prostate cancers every year. Treatment is pretty standard. There are just several thousand cases of childhood ALL in North America. The research base is not sufficient to definitely state this is the only treatment protocol.
If you look at the different protocols for all (high or low risk, etc.) you will notice that the differences are slight. Do we give predisone or dexamethasone first and for how long? Do we do the majority of drugs orally or I? Look hard at the protocols. There is nothing radically different in the treatments. The changes we see today are incremental and evolutionary, not revolutionary.
I am glad that we had Zach on the study. Not only has Zach done well, but perhaps his slight contribution will help others.
We, too, have had to make the decision. We decided to put Matthew into the study on moral grounds. Twenty to thirty years ago, children in Matt's position had a 25% survival rate. Matt's doctors have put his chances at approximately 70%.
We know that his odds are better than they would have been years ago because of other children who participated in the study, children whose parents certainly wished with their whole hearts that they had never even heard of such a study. How could we use the benefits of their risks without taking some of our own?
Matt is going to have a longer duration of treatments than he would otherwise had have. We hope and pray that they will not cause him too much extra pain or suffering. And yet, we want him to live, and we want this disease eliminated from the planet.
Bill and Judy
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