Clinical trial NCT01032811: Pilot Study Of Primary And Secondary Attention-Deficit/Hyperactivity Disorder Among Survivors Of Childhood Cancer
Official title: Pilot Study Of Primary And Secondary Attention-Deficit/Hyperactivity Disorder Among Survivors Of Childhood Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADHD
Cancer
Keywords: ADHD, childhood cancer
ADHD/Secondary ADHD Among Survivors of Childhood Cancer
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited through consecutive enrollment in the SJCRH Leukemia, Neuro-Oncology, Radiation Oncology, and After Completion of Therapy (ACT) clinics. Participants will be accrued using a broad stratification process for gender (female, male) and age (12-14 years, 15-17 years) for each diagnosis group (brain tumor, ALL).

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
measure: This study will examine the relationship between ADHD/S-ADHD symptoms and smoking (including intentions, behaviors, and motivators) among adolescent survivors of childhood cancer.
timeFrame: 1 year
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St . Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Sean Phipps, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: