Introduction

This summary is intended to provide a general overview of the Children's Oncology Group (COG) study ACCL1033. It tells who can be in this study and other basic information about the study. The informed consent contains the full details of the study. You can get this from your oncologist.

ACCL1033 is a Cancer Control and Supportive Care (CCLSC) Study. CCLSC studies are performed to help learn how to best deal with, or prevent complications of cancer and cancer treatment.

If you consent to being a part of this study, you or your child may be assigned to an intervention program. Whether you and your child are assigned to the intervention program or not is decided by a process called randomization. Randomization means that the intervention program is assigned by chance. It is a lot like flipping a coin, except that it is done by computer. The randomization process is described in the COG Family Handbook for Children with Cancer.

Participating in a clinical trial is voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find more information about clinical trials at www.childrensoncologygroup.org.

Brief Title:

ACCL1033

Official Title:

A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

Trial Opening Date

ACCL1033 opened on 02/21/12. The study committee plans to enroll 608 patients, which should take about 5 to 6 years.

General Patient Eligibility

• Age: 1 - 25 years
• Diagnosis: acute lymphocytic leukemia (ALL) diagnosed at age 21 or younger
• Completed at least 6 months of maintenance chemotherapy including mercaptopurine (6MP) in pill form, and due for at least 6 more months of maintenance chemotherapy
• Patient and parent/caregiver must speak English or Spanish; parent/caregiver must agree to participate in a daily supervised medication administration routine
• Patients with Down syndrome or those who have participated in a previous clinical trial designed to improve adherence are not eligible for this study.

Please consult your doctor to determine whether your child may participate in this study.

General Background and Study Goal

Taking chemotherapy pills exactly as prescribed is important to the success of ALL therapy. Missing doses over time can lead to an increased risk of relapse. Helping patients and their families remember all their medications may lead to a higher success rate. This study will compare:

1. the effects of a multi-component intervention program designed to help people with ALL take their medication as directed with
2. the effects of an educational program only.

Some patients will be randomized to a group that will receive the multi-component intervention program, designed to help them remember to take their medications; the other group will be randomized to watch an educational video and to continue with usual care (whatever is normally done at their clinic to help people remember to take their medications).

All patients will receive a special medication bottle for 6MP that electronically records every time the bottle is opened. All parents and patients age 12 and older will be asked to answer questions about their medication-taking. All parents and patients age 12 and older will watch the educational video. Patients assigned to the multi-component intervention program will also receive:

• a personalized medication schedule
• text message medication reminders (sent to parents for patients under age 12; sent to parents and patients age 12 and older)
• parent/caregiver training to supervise the patient's taking of medication.
• Taking part in this study does not change the maintenance chemotherapy the patient would normally receive.

Summary of the Treatment

After consenting to be part of the study, patients are randomized to the education and reminder intervention arm (IP) or the education only (EDU) arm.

All patients will store 6MP in a bottle with a special cap that records every time the bottle is opened.

One month after enrolling in the study:

• all parents and patients age 12 and older will view a video education program.

Additionally, patients assigned to the intervention arm (IP) will:

• receive a customized 6MP schedule
• begin receiving text message reminders to take 6MP. If the patient (age 12 or older) or parent does not have a cell phone with text messaging, the study will provide one for each of them to use during the study.
• a parent or designated caregiver will watch the patient take their medication every day

Participation on the study lasts for about 6 months.

Blood is drawn at 6 times during this study, during regularly scheduled blood draws. Blood will be used to identify how the patient's body handles 6MP and to measure 6MP levels in the patient's blood.

Participants will complete questionnaires at 6 points during the study. Questionnaires will be completed on days when patients are already scheduled for clinic visits. Patients on this study do not require extra visits to clinic.

As of 8/13/18: The study has reached enrollment goals and has closed to accrual for all patients.

Risks and Side Effects

All risks and side effects will be explained in detail by your healthcare team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the clinical trial or other aspects of care. The study consent form has more details about possible side effects of the treatment in this study.

Contact Information

Your child's oncologist and nurses are the best source for further information.

Principal Investigator

Study Chair: Smita Bhatia, MD, MPH

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS