Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 4 - Any |
| Updated: | 10/12/2018 |
| Start Date: | August 17, 2017 |
| End Date: | October 2019 |
| Contact: | Lisa M. Jacola, PhD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI: A Pilot Study
Computer-based cognitive training has been found to be helpful for improving attention and
working memory in pediatric and adult patients with existing cognitive difficulties. A
previous study was conducted at St. Jude Children's Research Hospital with survivors of
childhood cancer who were experiencing difficulties with attention and/or working memory.
Findings from that study indicated that the use of Cogmed, computer-based cognitive training,
is effective in improving attention and working memory in survivors.
Researchers want to learn whether Cogmed intervention completed at the end of therapy for
acute lymphoblastic leukemia will be effective for all survivors (i.e., regardless of whether
they have existing difficulties).
PRIMARY OBJECTIVES:
- To evaluate the overall participation rate in a randomized, standard-of-care controlled
trial of computerized cognitive intervention administered at the end of TOTXVI therapy.
- To estimate the study completion rate in a randomized, standard-of-care controlled trial
of computerized cognitive intervention administered at the end of TOTXVI therapy.
- To estimate the compliance rate for participants randomized to the intervention arm of a
computerized cognitive intervention administered at the end of TOTXVI therapy.
- To estimate the standard deviation for the overall cohort on a measure of working
memory.
- To use neuroimaging data collected in the context of the Total Therapy XVI trial to
explore candidate biomarkers predictive of response to the computerized cognitive
intervention.
working memory in pediatric and adult patients with existing cognitive difficulties. A
previous study was conducted at St. Jude Children's Research Hospital with survivors of
childhood cancer who were experiencing difficulties with attention and/or working memory.
Findings from that study indicated that the use of Cogmed, computer-based cognitive training,
is effective in improving attention and working memory in survivors.
Researchers want to learn whether Cogmed intervention completed at the end of therapy for
acute lymphoblastic leukemia will be effective for all survivors (i.e., regardless of whether
they have existing difficulties).
PRIMARY OBJECTIVES:
- To evaluate the overall participation rate in a randomized, standard-of-care controlled
trial of computerized cognitive intervention administered at the end of TOTXVI therapy.
- To estimate the study completion rate in a randomized, standard-of-care controlled trial
of computerized cognitive intervention administered at the end of TOTXVI therapy.
- To estimate the compliance rate for participants randomized to the intervention arm of a
computerized cognitive intervention administered at the end of TOTXVI therapy.
- To estimate the standard deviation for the overall cohort on a measure of working
memory.
- To use neuroimaging data collected in the context of the Total Therapy XVI trial to
explore candidate biomarkers predictive of response to the computerized cognitive
intervention.
Participants enrolled on the TOTXVI protocol at SJCRH will be randomized to either complete
the Cogmed intervention at the end of their therapy, or to a standard-of-care condition.
Cogmed is a computer-based cognitive training program that consists of rotating exercises
that train attention and working memory. The exercises are presented in a child-friendly,
game-like format. Training is completed at home in 25 sessions for 15-45 minutes each weekday
for 5-9 weeks. A research team member serves as a coach who monitors progress and provides
support through weekly phone calls with study participants and their parents/guardians.
Information regarding compliance and performance is tracked over the internet and used to
tailor feedback during weekly telephone coaching.
Neurocognitive assessments will be conducted at baseline, immediate-post (3-4 months after
baseline), and 8 month follow-up (12 months after baseline).
the Cogmed intervention at the end of their therapy, or to a standard-of-care condition.
Cogmed is a computer-based cognitive training program that consists of rotating exercises
that train attention and working memory. The exercises are presented in a child-friendly,
game-like format. Training is completed at home in 25 sessions for 15-45 minutes each weekday
for 5-9 weeks. A research team member serves as a coach who monitors progress and provides
support through weekly phone calls with study participants and their parents/guardians.
Information regarding compliance and performance is tracked over the internet and used to
tailor feedback during weekly telephone coaching.
Neurocognitive assessments will be conducted at baseline, immediate-post (3-4 months after
baseline), and 8 month follow-up (12 months after baseline).
Inclusion Criteria:
- Currently enrolled and receiving treatment for acute lymphoblastic leukemia (ALL) on
the TOTXVI therapy protocol at St. Jude Children's Research Hospital
- At least 4 years of age at the time of randomization
- Primary language is English
- Parent/legal guardian/caregiver that speaks English available to assist in
participant's training
Exclusion Criteria:
- Significant cognitive impairment as determined by either an IQ of ≤ 70 or by clinician
judgment
- Major sensory or motor impairment that would preclude valid cognitive testing
- Major psychological condition that would preclude completion of the intervention
- History of significant CNS injury or disease predating or unrelated to cancer
diagnosis
- Documented ADHD predating cancer diagnosis
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Lisa M. Jacola, PhD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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