- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00636337
Inattention in Childhood Cancer Survivors (TRICCS)
TRICCS: Targeting Inattention in Childhood Cancer Survivors
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center Preston Robert Tisch Brain Tumor Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Insufficient fluency in English. Participants who are currently taking stimulant medications (stable dose for at least 30 days) for attentional difficulties, but who meet inclusion criteria listed below will be allowed to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Computer program training for attention difficulties.
Other Names:
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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.
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Comparison computer program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Memory
Time Frame: 2 months and 3 months
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2 months and 3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Feasibility
Time Frame: once a month for 3 months
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once a month for 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristi Hardy, PhD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00003249
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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