As soon as possible after diagnosis, parents and older children sit down with the medical team to discuss treatment options. If your child is being treated at a COG hospital, the first discussion is usually about standard treatment and a clinical trial (if a trial is open and your child qualifies). Parents are sometimes very conflicted about choosing a treatment.

The choice to opt for standard treatment or a clinical trial is a strictly personal one, but parents should only make it after they are certain they understand the implications of each path. The treatment team is legally and ethically bound to inform parents of the full range of appropriate treatment options available to their child, and to help them understand what each option entails before asking them for written consent to begin a particular treatment plan. Members of the treatment team may not coerce or deceive the parents into choosing a treatment. Once the parents have consented to standard treatment or a clinical trial, the doctor must abide by their decision.

Informed consent process

Before a child is enrolled in a clinical trial, the parents need to sign an informed consent form. True informed consent is a process, not merely an explanation and signing of documents. Informed consent requires that:

• All treatments available to the child have been explained—not just the treatment available at your hospital or through your doctor, but all the treatments that could be beneficial, wherever they are given.
• All treatment options are thoroughly discussed, with all the possible benefits and risks clearly explained.
• The parents and, to the extent possible, the child, have discussed these options and chosen the treatment they want.
• Aspects of the study that are considered experimental and those that are standard are clearly described.

An informed medical decision is one that weighs the relative merits of a therapy after full disclosure of benefits, risks, and alternatives. During the discussions between the medical team and family, all questions should be answered in language that is clearly understood by the parents and child or teen, and there should be no pressure on parents to enroll their child in a study. The objective of the informed consent process is that all family members understand their options, are comfortable with their choice, and can comply with it. Studies show that the more questions parents ask during the informed consent process, the better they understand what they are agreeing to.

We had many discussions with the staff prior to signing the informed consent to participate in the clinical trial. We asked innumerable questions, all of which were answered in a frank and honest manner. We felt that participating gave our child the best chance for a cure, and we felt good about increasing the knowledge that would help other children later.

Informed consent is a process that occurs over several meetings. During the meetings, the pediatric oncologist and sometimes other members of the treatment team provide information and the parents ask questions (and get answers). However, the informed consent process does not always work as it should for a variety of reasons, including the parents’ state of mind, the communication style of the doctor, and the system in place to discuss treatment options. Most often, this situation is the result of miscommunication arising from some combination of the following:

• No formal meeting times were set in advance to discuss treatment options, so parents didn’t understand the importance of the discussion they were having with the doctor and the treatment team.
• Parents, who are tired, confused, and mentally numb, appear to understand things they are barely hearing.
• The doctor does not recognize that the parents aren’t following what he is saying and that they need more guidance and time to absorb the choices.
• The doctor is unconsciously promoting the choice she believes is the best one and she interprets the lack of questions as agreement.
• There is no one in the room except the doctor and the parents; therefore, there is no one to help with communication.

Parents may want to invite a trusted friend or their child’s pediatrician to attend the informed consent meetings to ensure they understand their options. These people can be physically present, on the telephone, or can use software such as Skype®.

When my son was diagnosed, we were told we had two options: a clinical trial or standard treatment. We decided to get a second opinion before making our decision. Our pediatrician, my husband, and I met in the pediatrician’s office for a telephone conference with a pediatric oncologist from a major treatment center. We each presented our concerns. Our pediatrician thought of some issues neither my husband nor I had considered. I think we all came away better informed of our options.

Some families seek a second opinion to help sort out their options. It is most useful to get a second opinion from a center that treats significant numbers of children with your child’s diagnosis. Most pediatric oncologists are willing to arrange the second opinion for you.

My son Justin was diagnosed with standard risk B-cell ALL when he was 8 years old. We were at a small hospital with one oncologist who had just completed her residency. We were offered standard treatment or ALL0331, a COG phase III trial that had one standard arm and three experimental arms. We consulted with ped-onc staff at a large and respected children’s hospital in another state, and they said those were the same options they offered their families in similar circumstances, so we signed up. We were randomized to one of the experimental arms—same induction but an intensification with an additional medication.

Studies have shown that when treatment team members who are not doctors are present during the informed consent meetings, parents have a better understanding of their choices. You may want to ask for a nurse or a social worker to be present during the meetings.

Two days after my child was diagnosed, the oncologist told me it was time to begin treatment. I do remember him talking a lot, but I swear it actually sounded like “Wah, wah, wah, protocol, wah, wah, wah, very successful, wah, wah, wah, sign here.” And I did. It was several days before it sank in that I had authorized an experimental treatment protocol and not the standard treatment. The irony is that I worked in clinical research. I knew how this was supposed to go. But I was alone and tired and frightened and went along like a sheep. In the end it was my responsibility to hold it together and ask what needed to be asked. But it just wasn’t in me at the time. Later, I told the doctor this and he was astonished to learn that I hadn’t heard a word he said.

Assent

Assent means that children and adolescents are involved in decisions about their treatment. Children younger than age 18 do not have the legal right to refuse standard treatment for their cancer. They do, however, have the right to participate in decisions about experimental treatments. All clinical trials are considered experimental treatments. Regardless of whether children will receive the standard treatment or an experimental treatment, they have the right to have the disease, treatment, and procedures explained to them at an age-appropriate level.

Doctors and parents are required to allow children to make their wishes known about their treatment. According to the American Academy of Pediatrics (AAP), assent means that the child:

• Is aware of the nature of his or her disease
• Understands what to expect from tests and treatments
• Has had his or her understanding assessed
• Has had an opportunity to accept or reject the proposed treatment

Parents can read or download a copy of the AAP policy statement (“Informed Consent, Parental Permission, and Assent in Pediatric Practice”) from the AAP website. In part, the policy states, “In situations in which the patient will have to receive medical care despite his or her objection, the patient should be told that fact and should not be deceived.” This policy applies to standard treatment.

Clinical trials, however, are research, and IRBs decide whether the child’s assent is needed. If parents and the child or teen disagree about treatment, discussions are usually held with a mediator (for example, a social worker or pediatric psychologist) to try to reach an agreement. If parents and their child or teen still disagree, an advocate for the child is appointed and a decision about treatment is made by the hospital ethics committee.

In short, parents can legally make decisions about standard care, but both parents and children have decision-making rights about whether or not to participate in clinical trials.

Saying no to a clinical trial

Parents, children, and teens have the legal right to decide whether or not to participate in a clinical trial. If the family chooses for the child not to participate in the proposed clinical trial, or if their insurance refuses to pay for the treatments given in the clinical trial, the child or teen is given the best-known treatment (standard treatment) for his type of leukemia.

We just were not comfortable with the concept of a clinical trial. It seemed like gambling to us. We also felt totally overwhelmed about making decisions on important subjects that we didn’t understand. Even though we asked many, many questions, we just couldn’t come to grips with the whole idea in the two days after our daughter was diagnosed. So, we declined the trial and had the best known treatment. We are happy with our decision.

Saying yes to a clinical trial

If you decide to enroll your child in a clinical trial, the form you sign will have language similar to the following: “The study described above has been explained to me, and I voluntarily agree to have my child participate in this study. I have had all of my questions answered, and understand that all future questions that I have about this research will be answered by the investigators listed above.” It is a good idea to keep a copy of the signed form.

Sean missed the deadline for enrolling in a clinical trial when he was diagnosed. However, when his cancer returned, we did enroll him on a trial. The particular trial he was in was a randomized computer trial that decided if he was getting one or two extra chemotherapy agents. We felt if we enrolled him in the trial, maybe the results would help other children.

Removing your child from a clinical trial

Parents have the legal right to withdraw their child from a clinical trial at any time, for any reason. But before doing so, it’s a good idea to discuss questions or concerns with your child’s oncologist. The decision to withdraw from a trial should not be held against the parent, and the child will still receive the best available care for his type of leukemia. On the consent form signed by parents, there will be language similar to this: “You are free not to have your child participate in this research or to withdraw your child at any time without penalty or jeopardizing future care.”

Jesse was enrolled in a clinical trial to assess long-term consequences of radiation. The testing was free, and we were glad to participate. Unfortunately, the billing department of the hospital continually billed us in error. We tried to correct the problem, but it became such a hassle that we withdrew from the study.