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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032811
• Other study ID #: SADHD1
• Status: Completed
• Phase: N/A
• First received: December 14, 2009
• Last updated: September 5, 2013
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2013
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Cancer

Locations

Country	Name	City	State
United States	St . Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No

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