Neuropsychological and Behavioral Testing in Younger Patients With Cancer

Recruiting at 183 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Oncology Group

Disqualifiers: Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

This research trial studies neuropsychological (learning, remembering or thinking) and behavioral outcomes in children and adolescents with cancer by collecting information over time from a series of tests.

Research Team

Leanne M Embry

Principal Investigator

Children's Oncology Group

Eligibility Criteria

Inclusion Criteria

The patient must be currently be enrolled or plan to be enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning

The patient must have receptive and expressive language skills in English, French, or Spanish; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted

All patients and/or their parents or legal guardians must sign a written informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neuropsychological and Behavioral Testing

Participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis

60 months

3 visits (in-person)

Follow-up

Participants are monitored for neuropsychological and behavioral outcomes over time

12 months

Treatment Details

Interventions

• Cognitive Assessment
• Quality-of-Life Assessment

Participant Groups

Group I: Observational (neuropsychological and behavioral tests) Experimental Treatment 2 Interventions

Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.

Cognitive Assessment is already approved in United States, European Union for the following indications:

Approved in United States as Stereotactic Radiosurgery for:

• Brain metastases
• Primary brain tumors
• Arteriovenous malformations
• Trigeminal neuralgia

Approved in European Union as Stereotactic Radiosurgery for:

• Brain metastases
• Primary brain tumors
• Arteriovenous malformations
• Trigeminal neuralgia

Approved in United States as Stereotactic Body Radiation Therapy for:

• Lung tumors
• Liver tumors
• Abdominal tumors
• Spine tumors
• Prostate tumors
• Head and neck tumors

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Lung tumors
• Liver tumors
• Abdominal tumors
• Spine tumors
• Prostate tumors
• Head and neck tumors

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+