PRO-CTCAE: Creating and Validating Child Adverse Event Reporting in Oncology Trials: Pediatric PRO-CTCAE Project (CLOSED TO ACCRUAL)

Description

The purpose of this research study is to develop a way for children and adolescents who are between 7 and 20 years old and getting chemotherapy to report how they feel when getting chemotherapy. This includes asking about a symptom or change in the body that could be related to the chemotherapy. The questions asked are about feelings (such as being tired, worried or mad) and quality of life during treatment for cancer.

Young participants enrolled in chemotherapy studies have not been asked about how the chemotherapy is affecting their lives. This research study is designed to answer the question: “What are the best ways to ask 7 to 20 year olds about symptoms they may be experiencing in chemotherapy trials?”

Objectives

• To learn how well children and adolescents and their caregivers understand and respond to a questionnaire that is designed to describe their symptoms and feelings while they are on chemotherapy.
• To learn how well the questionnaire measures these symptoms over a long period of time for children or adolescents with newly diagnosed cancer who are in treatment.
• To compare how the children or adolescents, their caregivers and their doctors respond to the same questionnaire.

Eligibility criteria, among others, include

Inclusion Criteria

• Participant is 7 to 20 years of age, in treatment for cancer, at any point in their treatment.
• Participant is English- speaking.
• Parent/Guardian of eligible participant (7 to 20 years of age) has agreed to participate.
• Parent/Guardian of eligible participant (7 to 20 years of age) is English- speaking.

Exclusion Criteria

• Participants with cancer who are less than 7 years of age or who are 21 years of age and older.

Principal Investigator

Justin Baker, MD