Pilot Study Of Primary And Secondary Attention-Deficit/Hyperactivity Disorder Among Survivors Of Childhood Cancer

NCT ID: NCT01032811

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-09-30

Brief Summary

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This is a pilot study that will be an exploratory investigation of the rate of occurrence of ADHD/S-ADHD in adolescent cancer survivors. The procedures that will be used for identifying attention problem symptoms, determining the frequency and severity of such symptoms, and characterizing the level of impairment resulting from the symptoms are novel to pediatric oncology research.This pilot study will draw from the approach used in traumatic brain injury research of post-injury effects to illuminate more clearly the nature of attentional late effects experienced by survivors of childhood cancer.

Detailed Description

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1. This study will investigate the feasibility of assessing symptoms of developmental ADHD and "secondary ADHD" (S-ADHD) among adolescent survivors of childhood cancer using a structured diagnostic clinical interview procedure. (S-ADHD describes an acquired clinical presentation that is consistent with the diagnostic criteria of ADHD).
2. This study will provide preliminary estimates of the rate of occurrence of ADHD/S-ADHD among adolescent survivors of childhood cancer as compared to the prevalence of developmental ADHD in the general population.
3. The study will examine the relationship between ADHD/S-ADHD symptoms and laboratory measures traditionally used to assess specific components of attention (e.g., CPT) in survivors of childhood cancer.
4. The study will examine the relationship between ADHD/S-ADHD symptoms and smoking (including intentions, behaviors, and motivators) among adolescent survivors of childhood cancer.

Conditions

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ADHD Cancer

Keywords

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ADHD, childhood cancer ADHD/Secondary ADHD Among Survivors of Childhood Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Participants

St. Jude Children's Research Hospital patients from Leukemia, Neuro-Oncology, Radiation Oncology, and After Completion of Therapy (ACT) clinics.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients treated for acute lymphoblastic leukemia (ALL) OR primary central nervous system (CNS) tumor.
2. Completed primary treatment at least one year prior to enrollment with no evidence of active disease.
3. Age 12-17 years inclusive at the time of enrollment.
4. At least one parent/guardian must be present.
5. Participant and parent are able to understand English.
6. Participant and parent are willing and able to provide consent/assent according to institutional guidelines.
7. Parent/guardian signs consent.

Exclusion Criteria

1.Significant impairment in intellectual functioning (e.g., full or estimated IQ \<70) as documented in the medical record.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Phipps, Ph.D

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St . Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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SADHD1

Identifier Type: -

Identifier Source: org_study_id