Feasibility of Home-Based Computerized Cognitive Training during Maintenance Therapy for ALL
Study ID: STU 072017-019
Many survivors of acute lymphoblastic leukemia (aLL) experience neurocognitive dysfunction; most commonly in processing speed (PS), visual-motor abilities, attention, working memory (WM), and executive functioning 1-3. Cogmed, a computerized, home-based cognitive training program, has been tested in many populations, including children with aDHD4,5 and english-speaking survivors of pediatric aLL6,7, with demonstrated improvements in task performance. This project seeks to establish feasibility of incorporating Cogmed into the maintenance phase of aLL therapy for both english- and Spanish-speaking children. We will gather preliminary feasibility and efficacy data needed to follow this pilot with a randomized assessment of the impact of an early intervention on neurocognitive outcomes in this population.
Participant Inclusion/Exclusion * Participants will be patients, ages 6-18 years, who are in maintenance phase chemotherapy for ALL at Children[Single Quote]s Health-Children[Single Quote]s Medical Center. This age range was selected to correspond with ages for which the Cogmed program has been validated in non-oncology samples. Eligible patients will include those who are English or Spanish speaking and 6-18 years old at study entry. Patients are not required to enter a specific therapeutic trial but must be receiving standard maintenance therapy defined as including daily 6-mercaptopurine, weekly methotrexate, and intrathecal chemotherapy approximately every 12 weeks, with or without vincristine/steroid pulses. Exclusion criteria will include: 1) intellectual, motor, or sensory problems preventing computer use; 2) diagnosis of any Axis I mental health disorder (e.g., depression, as documented in the medical record) that either precludes or takes treatment precedence over participation in this trial. * Participating patients[Single Quote] parents will also be asked to complete questionnaires. This age range was selected to correspond with ages for which the Cogmed program has been validated in non-oncology samples. An eligible * Parent * will be defined as an adult of any age, with whom the patient lives at least 50% of the time and who identifies himself/herself as the patient[Single Quote]s primary caretaker at least 50% of the time.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- NAOMI JOAN WINICK
ST. BALDRICKS FOUNDATION
Specific aims: Children treated for aLL, without cranial radiation, are at risk for neurocognitive late effects, including deficits in attention and WM1-3. Participating patients will be provided with Cogmed, a program that targets WM, during maintenance therapy, not after its completion, hoping that early intervention will more effectively ameliorate chemotherapy-induced neurocognitive dysfunction. aim 1: Determine the feasibility of children ages 6-18, completing the Cogmed program at home during the maintenance phase of therapy. The trial will be deemed feasible if at least 75% of patients complete at least 75% of the Cogmed sessions over 5-8 weeks. aim 2: Determine correlations between likelihood of completing Cogmed sessions and patient demographic factors including age, primary language, and annual household income. exploratory aim: Gather preliminary efficacy data via assessments of working memory, processing speed and attention prior to, at the completion of the CogMed program, and again 6 months later.