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Completed

NCT Number: NCT01032811

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

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

  • 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).
  • 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.
  • 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.
  • The study will examine the relationship between ADHD/S-ADHD symptoms and smoking (including intentions, behaviors, and motivators) among adolescent survivors of childhood cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  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.

    Time frame: 1 year

  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.

    Time frame: 1 year

Secondary outcomes

  1. This 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.

    Time frame: 1 year

  2. This study will examine the relationship between ADHD/S-ADHD symptoms and smoking (including intentions, behaviors, and motivators) among adolescent survivors of childhood cancer.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 16, 2009
Registry last updated
Sep 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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