Inattention in Childhood Cancer Survivors (TRICCS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||TRICCS: Targeting Inattention in Childhood Cancer Survivors|
- Memory [ Time Frame: 2 months and 3 months ] [ Designated as safety issue: No ]
- Feasibility [ Time Frame: once a month for 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||November 2012|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
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
Computer program training for attention difficulties.
Placebo Comparator: 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.
Comparison computer program
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636337
|United States, North Carolina|
|Duke University Medical Center Preston Robert Tisch Brain Tumor Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Kristi Hardy, PhD||Duke University|