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.

Study Overview

• Status: Completed
• Conditions: Cancer; ADHD

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St . Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 year
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.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	1 year
This study will examine the relationship between ADHD/S-ADHD symptoms and smoking (including intentions, behaviors, and motivators) among adolescent survivors of childhood cancer.	1 year

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Sean Phipps, Ph.D, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): September 6, 2013
• Last Update Submitted That Met QC Criteria: September 5, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: ADHD, childhood cancer; ADHD/Secondary ADHD Among Survivors of Childhood Cancer
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: SADHD1