Introduction

This family protocol summary provides a general overview of the Children's Oncology Group (COG) study ACCL10P1. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form. You can get this from your oncologist.

ACCL10P1 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. ACCL10P1 compares two different treatments. These treatments are called study arms. Usually, one study arm is the standard or the best proven current treatment. The other study arm has some changes or additions. The new treatment is thought to be at least as good as the standard treatment. It is not known if the new treatment will be better than the standard treatment. If you consent to being a part of this study, your child will be assigned to one of two different study arms.

In a Phase III trial, each child is assigned to a study arm by a method called randomization. This is a process like flipping a coin that assures that each child has a fair and equal chance of being assigned to any of the study arms. This makes sure the study arms can be compared fairly. The randomization process is described in the COG Family Handbook for Children with Cancer.

ACCL10P1 is also considered a pilot study. A pilot study is done to help determine if the treatment can be carried out on a larger basis, in multiple hospitals, with more patients. This study is open only at a limited number (9) of hospitals.

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.

Study Number

ACCL10P1

Study Title

Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study

Study Opening Date

ACCL10P1 opened on November 4, 2013. The ACCL10P1 committee hopes to enroll 60 patients.

General Patient Eligibility

  • 6-16 years old at time of enrollment onto ACCL10P1
  • Newly diagnosed (not relapsed) with a brain tumor
  • Completed radiation within 3±1 calendar months
  • Has an identified caregiver who is willing and able to oversee the training practice during the intervention period (i.e., for 5-9 weeks starting approximately 3 months after completion of CRT)
  • Has access to a telephone and phone number where they can be reached
  • Both patient and caregiver must read, speak, and understand English

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

General Background and Study Goal

Children with brain tumors are at risk to develop problems with learning and information processing after receiving radiation therapy. Radiation treatments may lower the IQ (intelligence quotient) and cause changes in memory and attention skills, which may later result in problems in school and learning.

Computerized cognitive training is a tool that may help protect brain function in children who are being treated with cranial radiation. There are studies that show that cognitive training is effective in improving memory in children with brain injuries. Other studies have looked at using computerized cognitive training following completion of all cancer treatment. ACCL10P1 will study how effective CT training is when it is started immediately after the end of the radiation phase of therapy.

Summary of the Treatment

ACCL10P1 compares two different types of computerized learning and memory training programs, adaptive and non-adaptive.

"Adaptive"

  • The program changes the level of difficulty as the participant answers questions correctly. The questions and problems become more challenging or "harder" if earlier problems are answered correctly. It is called adaptive because the program adapts or adjusts to an individual patient's responses.

 

"Non-adaptive"

  • The program does not adapt based on participant responses.

 

The non-adaptive program is the standard of care in this study. The adaptive program is considered the new treatment being tested. The ACCL10P1 study will compare how often participants used the two different programs and evaluate how useful the programs were.

Special Considerations

  • Children on this study must speak English.
  • Three clinic visits (in addition to treatment visits) are required for this study.
  • Children will need to undergo a training session in the use of the Cogmed programs in the clinic before beginning the computerized cognitive training program at home.
  • A computer with internet will be provided for families who do not have their own, during the time they are participating in the study.
  • It is recommended that participants use the Cogmed program 3-5 sessions each week for 5-9 weeks, for a total of 25 sessions.
  • There will be weekly contact with a treatment “coach” to help with any concerns or difficulties the participants may have.
  • Standardized neuropsychological evaluation (IQ tests) will be done at study entry, within three weeks after completion of the training program, and 6 months after completion of the training program.
  • Small money stipend will be provided as the participants participate in the study.

Risks and Side Effects

All risks and side effects will be explained by your treatment 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. Please refer to the consent form for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your child’s oncologist and nurses are the best sources for further information.

Study Chairs

Kristina Hardy, PhD

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS  

Initial development Name Date
Written by Cindy J. Cochran, MSN, RN, CPNP-PC/span> February 5, 2016
Reviewed/approved by (PI) Kristina Hardy, PhD February 12, 2016
Ongoing review
Reviewed and updated by Elizabeth Bell, RN September 8, 2016
Cindy Cochran, RN March 18, 2017
February 2, 2018

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