Introduction

This family protocol summary provides a general overview of the Children's Oncology Group (COG) study ANUR1131.  It tells who is eligible and gives basic information about the study. More details about the study are in the consent form and protocol.  You can get these from the researchers at your institution.

ANUR1131 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. They may study traditional medical treatments, non-traditional medicines and treatments (called complementary or alternative treatments) and other approaches. CCLSC studies may focus on complications that affect the quality of life or on life expectancy, or they may involve measuring and evaluating behaviors of the child with cancer or their family members.

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. You can discuss any questions with your treatment team.

Study Number

ANUR1131

Study Title

Music Video for AYA - Parent Communication and Resilience

Study Opening Date

COG ANUR1131 opened on 4/23/12 and closed to enrollment on 5/31/2016.

It is a limited institution study open at 6 COG institutions.  These 6 sites are:

• Riley Hospital for Children (Indianapolis, IN)
• Children's Healthcare of Atlanta (Atlanta, GA)
• University of Missouri-Kansas City: Children's Mercy Hospitals and Clinics (Kansas City, MO)
• Children's Hospitals and Clinics of Minnesota (Minneapolis, MN)
• The University of Texas Health Science Center at San Antonio (San Antonio, TX)
• Cincinnati Children's Hospital Medical Center (Cincinnati, OH).

The following institutions are no longer enrolling patients on ANUR1131:

• University of Missouri-Kansas City: Children's Mercy Hospitals and Clinics (Kansas City, MO) (Effective June 1, 2015)
• The University of Texas Health Science Center at San Antonio (San Antonio, TX)  (Effective June 1, 2015)
• Cincinnati Children's Hospital Medical Center (Cincinnati, OH) (Effective January 2016)

General Patient Eligibility

• Age: 11- 24 years old
• Diagnosis: cancer of any type requiring chemotherapy
• One parent  available to participate in all parent sessions

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

General Background and Study Goal

Hospitalization and treatment for cancer can be stressful. We know from previous research that creating a music video is helpful in supporting adolescents and young adults (AYAs) during their cancer treatment. In this study, we want to learn how the addition of parent support programs may help parents and provide additional help to AYAs during their cancer treatment.

In this study, we are trying to find out if the music video and parent support programs can be used to help decrease distress, enhance family communication, and improve quality of life during cancer treatment.

We also want to know if these programs can help families learn more ways to cope with the cancer and treatment. We are especially interested in talking with AYA patients and their parents to find out what aspects of the program are helpful and how we can make them better.

For adolescents & young adults, there is evidence that participating in this study may help to:

• Provide an enjoyable experience while in the hospital or clinic
• Learn ways to cope with the cancer and treatments
• Learn ways for managing side effects of treatment
• Enhance family communication
• Stay connected with friends and family

For parents, participating in this study may help to:

• Learn ways to take good care of yourself and to be available to support your son or daughter.
• Learn ways AYA cope with cancer.
• Enhance family communication

Summary of the Treatment

For Adolescents/Young Adults

• You will answer questions about yourself and your experiences with the music video program.
• Your parent will answer questions about him/herself and experiences with the parent support program.
• You will receive a music video program. This program includes 5 visits from a music therapist who will help you write and create a music video.

For Parents

• You will be randomly assigned (flip a coin) to talk with a trained intervener two times or three times about ways to take care of yourself and ways to support your son or daughter during treatment.
• You will answer questions about yourself and experiences with the parent support program.

Special Considerations

The music video program was developed and tested by music therapists, nurses, and AYA patients who have undergone treatment similar to yours. We know from our previous research that this program was helpful in supporting AYAs during their cancer treatment.

The parent support program was also developed based on interviews with parents of AYAs receiving cancer treatment.

Risks and Side Effects

There are no physical risks to the AYA patient or the AYA's parent as a result of taking part in this study. Some of the questions may make you feel uncomfortable, but you will not have to answer any questions you do not want to answer and you may withdraw from the study at any time.

Contact Information

Your child's oncologists and nurses are the best sources for further information.

Study Co-Chairs

Family Protocol Summary Review/Approvals