Inattention in Childhood Cancer Survivors - Full Text View

Sponsors and Collaborators:	Duke University National Institutes of Health (NIH)
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00636337

Purpose

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.

Condition	Intervention
Childhood Cancer	Behavioral: Attention Training Behavioral: Placebo

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors Leukemia, Childhood Memory

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	TRICCS: Targeting Inattention in Childhood Cancer Survivors

Further study details as provided by Duke University:

Primary Outcome Measures:

Memory [ Time Frame: 2 months and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Feasibility [ Time Frame: once a month for 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Computer program training for attention difficulties.
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 Comparison computer program

Arms

Assigned Interventions

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

Computer program training for attention difficulties.

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

Comparison computer program

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.

Eligibility

Ages Eligible for Study:	8 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636337

Locations

United States, North Carolina
Duke University Medical Center Preston Robert Tisch Brain Tumor Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Kristi Hardy, PhD

Duke University

More Information

Responsible Party:	Duke University Medical Center ( Lee Jones, PhD )
Study ID Numbers:	00003249
Study First Received:	February 28, 2008
Last Updated:	May 4, 2008
ClinicalTrials.gov Identifier:	NCT00636337
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Pediatric
Brain Tumor
Acute Lymphoblastic Leukemia
Inattention
Childhood cancer survivors

Study placed in the following topic categories:

Brain Neoplasms
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma

ClinicalTrials.gov processed this record on January 16, 2009