Cognitive + Quality-of-Life Assessments for Childhood Cancer

Not currently recruiting at 189 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how cancer affects the brain and behavior in children and teens. It includes a series of tests that assess memory, thinking, and emotional well-being over time. The trial suits young patients already participating in a cancer treatment study who can communicate in English, French, or Spanish. Participants will engage in testing sessions with a psychologist to monitor any changes. As an unphased trial, this study provides a unique opportunity for patients to contribute to important research that could enhance future cancer care for young people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the neuropsychological and behavioral testing protocol because it offers a comprehensive way to understand how cancer affects cognitive and emotional development in younger patients. Unlike treatments that primarily focus on the physical symptoms of cancer, this approach uses a detailed battery of tests to assess intelligence, memory, attention, and quality of life over time. By evaluating these factors at multiple points post-diagnosis, the protocol aims to provide insights into the long-term impact of cancer and its treatments on a child’s mental and emotional health, which could lead to better supportive care strategies.

Who Is on the Research Team?

Leanne M Embry

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Assessment
• Quality-of-Life Assessment

How Is the Trial Designed?

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+