Inattention in Childhood Cancer Survivors

NCT00636337 | Completed

• 1 other identifier: Pro00003249
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim 1: To assess the feasibility and acceptability of a home-based, computerized cognitive training program with survivors of central nervous system-impacting pediatric cancer (e.g. acute lymphoblastic leukemia, brain tumors). Specific Aim 2: To estimate the effect size of this cognitive training program on measures of attention and working memory in survivors of childhood cancer in order to determine whether a larger-scale clinical trial is warranted.

Conditions

Childhood Cancer

Keywords

Pediatric; Brain Tumor; Acute Lymphoblastic Leukemia; Inattention; Childhood cancer survivors

Outcome Measures

Primary Outcomes (1)

• Memory

  2 months and 3 months

Secondary Outcomes (1)

• Feasibility

  once a month for 3 months

Study Arms (2)

1

EXPERIMENTAL

Participants meeting inclusion criteria will be provided with a laptop computer outfitted with a wireless card for the duration of the intervention and will be trained in the use of RoboMemo in the clinic by study personnel. Although many participants may have ready access to home computers, we decided that all participants will be required to use laptops provided by the study for two reasons: 1) to ensure that coaches and participants are blind to treatment condition (as described above), and 2) to ensure that participants will always have access to the intervention program (i.e., they will not compete with other family members for computer time). Once trained, children will complete the intervention at home. The intervention will consist of four 30- to 45-minute sessions per week for 8 weeks (total = 32 sessions). This intervention schedule is similar to the schedule employed by Klingberg and colleagues in their home-based CT trials with ADHD children.

Behavioral: Attention Training

2

PLACEBO COMPARATOR

The design will be a double-blind, placebo-controlled trial in which half of the participants will be randomized to the intervention condition and half will receive a comparison computer program. Specifically, participants assigned to the comparison (placebo) condition will complete a modified version of the CT at home. The treatment and comparison CT programs begin identically, at the lowest difficulty level. Those in the treatment condition will complete activities of increasing difficulty over the intervention period. Those in the placebo condition, in contrast, will complete the same basic tasks during each session of the intervention, regardless of performance. In this way, a true estimate can be obtained of the efficacy of the treatment program.

Behavioral: Placebo

Interventions

Attention Training BEHAVIORAL

Computer program training for attention difficulties.

Also known as: TRICCS, RoboMemo

1

Placebo BEHAVIORAL

Comparison computer program

2

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A T-score greater than the 75th percentile on either the Cognitive Problems/Inattention or the DSM-IV Inattention subscales of the Conners' Parent Rating Scale
• One or more standard deviations below the mean on the Attention or Working Memory Indices of the WRAML 2 \[56\] or Attention or Working Memory Indices that are one or more standard deviations below the participant's estimated IQ. These criteria are similar to those used in a trial of methylphenidate with survivors of childhood cancer.

You may not qualify if:

• Estimated IQ ≤ 70
• A motor, visual, or auditory handicap that prevents computer use
• A diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder, depression, autism, or Pervasive Developmental Disorder

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University Medical Center Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Neoplasms; Brain Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kristi Hardy, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 14, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2012
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

US (1)