Inattention in Childhood Cancer Survivors

NCT ID: NCT00636337

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-11-30

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.

Detailed Description

After obtaining written informed consent (parent) and assent (child), screening procedures will include administration of an abbreviated intellectual test battery, a working memory battery, and a computerized attention measure to the survivor (see specific Measures below). Our goal is to enroll 24 (12 ALL, 12 brain tumor) participants in the intervention phase of this prospective pilot study. To reach this goal, we anticipate needing to screen approximately 50 survivors, though enrollment will end when, or continue until, 24 eligible participants are identified and randomized to the intervention phase. Parents will complete questionnaire measures regarding their child's adaptive, behavioral, emotional, and attentional functioning. Follow-up interviewing will be conducted to clarify any potential problems identified on the questionnaires. The entire screening procedure is estimated to take approximately 90 minutes for the survivor and 30-45 minutes for parents. To maximize efficiency, two study personnel will work with families - one will complete testing with the child, while the other will complete questionnaires and follow-up interviewing with the parent. 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.

Conditions

Childhood Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Attention Training

Intervention Type: BEHAVIORAL

Computer program training for attention difficulties.

2

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BEHAVIORAL

Comparison computer program

Interventions

Attention Training

Computer program training for attention difficulties.

Intervention Type: BEHAVIORAL

Placebo

Comparison computer program

Intervention Type: BEHAVIORAL

Other Intervention Names

TRICCS; RoboMemo

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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.

Exclusion Criteria

1. Estimated IQ ≤ 70

2. A motor, visual, or auditory handicap that prevents computer use

3. A diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder, depression, autism, or Pervasive Developmental Disorder

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristi Hardy, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00003249

Identifier Type: -

Identifier Source: org_study_id

NCT00735202

Identifier Type: -

Identifier Source: nct_alias