Families & Kids

What's it like to be in a Clinical Trial?

Consultation

Initially you will meet with the Primary Investigator or Investigator, who will discuss the options available for your child. You will be asked to bring copies of all reports, scans and any prior treatment (chemotherapy, surgery, radiation therapy) with you to this appointment.

If one of the options available for your child is a POETIC trial, the investigator will fully discuss the protocol with you. You will learn about how the particular drug works on the cancer cell and what results and side effects are known when it is used to treat adult patients with this drug. Additionally, you will learn how the drug is given (for example, IV or oral), how many days your child will need to come for treatment, and what blood work and tests will be needed prior to starting, and during treatment.

You will also be told about any side effects other people have experienced while on the drug and how they would be managed for your child if they should occur. There will be sufficient time for you to ask questions and ensure that you have a full understanding of the trial and what will be required of you and your child. A copy of the consent form will be given to you to take home, read and become familiar with. You will be given time to think over what you have heard and to discuss this option with family members. You should write down any questions that you have so that we can review them with you at a later time.

Eligibility

The doctor and other members of the research team will carefully review your child's records to make certain that his or her history meets the eligibility criteria for this particular study. Your child may be scheduled for additional scans, biopsies, or line placement procedures. It may be necessary to wait a certain amount of time between the last treatment your child received and staring this new regimen. We call this the "washout period," which ensures that the prior drug is completely out of your child's system and they have recovered from that treatment enough so there will be no interactions between the two drugs.

Consenting

Once you have decided to participate on the clinical trial, you will have another appointment with the medical team. At this visit, you will meet with the study doctor and nurses. This is an opportunity to ask the questions that have come up for you since your consultation meeting. The doctor will review the study with you, answer your questions and if you choose to go forward, have you sign the consent to begin treatment. If you have an older child or adolescent, they may be asked to give verbal assent or agreement to the treatment. We believe this is important to offer your child a choice in their treatment, because there is no guarantee that this treatment will help your child. You will then be given information such as when treatment will begin, what time to come for your appointments, and whether it is necessary to fast for blood work prior to receiving drug.

Treatment

Your child may have the treatment in a clinic or day hospital, or if required due to your child's condition, may be treated in the hospital. Your child will be in a private or semi- private space with TV, Internet hook-up, and videos or other activities to keep busy with. The research nurse or bed area nurse will draw blood and may start an IV if needed, take vital signs and administer the study drug. Your child will be seen by the doctor and will be closely monitored by the nurse during and following the treatment. You will be given a calendar so that you can plan your schedule around treatment and assessment days.

The first day or two of treatment are often longer than later days. Some protocols require the drug be given at a slower rate and the patient be observed for a longer time period following the first infusion of the drug. This is for your child's safety in case they have a reaction to the drug.

There may also be blood draws for several hours following the drug dosing to monitor the level of the drug in your child's blood. We recommend that you bring a favorite game or special activity to entertain your child during this longer day of treatment. Child Life services are also available to support and play with your child.

Additional labs may be necessary over the next few days. If it is helpful for you to stay close to the hospital during this time, we can help set up a stay at the Ronald McDonald House for you and your family.

Depending on the particular study your child is on, there will be disease assessment scans scheduled at specific times. You will come to the hospital about two hours prior to your scan appointment to have your child's port accessed, any ordered blood tests drawn and possibly a clinic visit with your child's doctor before going for the scan. We know this can be an anxious time for parent and child.

For consistency, the same radiologist will read each of your scans. It is not always possible to have them read immediately and so your doctor will be in touch with you the next day or as soon as results are available. Whether you stay on this study or explore other options will depend on the results of the scan, the specifics of the protocol, and how your child has done with the current treatment.

During your time on the research study, we will be sure to communicate with your referring doctors and any other health care professionals that you want us to inform of your child's progress.

End of treatment

If it is necessary to come off treatment due to changes noted on the scan, unacceptable side effects, or simply if you choose to, your doctor will meet with you to fully explain the results of the scans/tests and what they mean. Your doctor will also provide information on what other treatment options are available and put you in contact with the appropriate medical group. If you do not choose another research study that we have available, we will direct you back to your referring oncologist. This person has probably known you for a long time and has your child's best interest at heart. Your child will continue to be monitored by the research team for at least thirty days, for the time specified by the particular protocol, or until your child starts a new treatment.

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