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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01276 | Registry Identifier | NCI Clinical Trial Registration Program |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training | Active Comparator | Participants will participate in computer-based cognitive training at the end of therapy. |
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| Standard-of-Care | No Intervention | At the end of therapy, participants will participate in the current standard-of-care which does not include computer-based cognitive training. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive training | Behavioral | 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. The program is completed at home for 15-45 minutes each weekday for 5-9 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in working memory | The magnitude and standard deviation of pre- to post-change in Spatial Span Backward will be estimated for each group and for the overall group. | Prior to intervention (baseline) and post intervention (up to one year later) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M. Jacola, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Participants will be randomized to either the intervention group to receive cognitive training or to the standard of care group who will not receive cognitive training.
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The study examiner (clinical research assistants or psychological examiners) will not know which group of participants is associated with each arm.
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|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |