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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03975 | Registry Identifier | NCI Clinical Trial Registration Program |
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The objective of this study is to estimate the feasibility and acceptability of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors. To achieve this goal, the investigators plan to study children undergoing radiotherapy for brain tumors randomly assigned to cognitive training administered via an iPad or virtual reality. Both groups will also participate in cognitive testing and exams using functional near infrared spectroscopy (fNIRS) pre- and post-intervention. The questions to be investigated are:
Findings from this study will be used to develop a larger, definitive trial with direct potential to improve cognitive outcomes for children treated for cancer using a safe and effective alternative to desktop- or laptop-based computerized cognitive interventions with great promise for improving quality of life.
The objectives of this study are:
Primary Objective:
• To estimate the participation rate, intervention adherence, and side effects of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors.
Secondary Objectives:
The investigators will use a randomized, single blind (psychology examiner), parallel group design (cognitive training via iPad versus virtual reality) to test hypotheses about behavioral and neurophysiological changes associated with cognitive training in childhood cancer survivors. The investigators will recruit patients who are being treated for a BT with radiotherapy. Patients will participate in study sessions in the Psychology Clinic during routine visits to St. Jude for radiotherapy. fNIRS studies will be conducted with participants randomized to both the virtual reality and iPad groups pre- and post- Cogmed training sessions. The time period between pre- and post-cognitive assessments will be 2 to 4 weeks for both virtual reality and iPad groups.
Participants will be enrolled until 30 patients initiating radiotherapy for a BT are evaluable, with approximately 20 randomized to the virtual reality group and 10 to the iPad group. The investigators expect to recruit and screen up to 45 patients to ascertain 30 eligible participants.
Enrollment and assessment will be completed approximately 18 months after the study begins. Imaging data will be processed approximately two years after the study begins, and study findings will be disseminated within three years after the study begins.
Data management and statistical analysis will be provided locally by the Department of Psychology, the Neuroimaging Division of Radiological Sciences and the Biostatistics Department at St. Jude Children's Research Hospital
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPad Cogmed Training | Active Comparator | The investigator will be randomizing participants to complete Cogmed training on an iPad. |
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| Virtual Reality Cogmed Training | Experimental | The investigator will be randomizing participants to complete Cogmed training in Virtual Reality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive training via iPad | Other | Participants will complete five sessions of the Cogmed training program on an iPad. Participants will complete sessions over the course of one to two weeks while on campus for radiotherapy. Each session will take place in the Psychology Clinic and consist of 15 to 20 minutes of Cogmed training. |
| Measure | Description | Time Frame |
|---|---|---|
| Participation Rate | The participation rate of this study (i.e., how many patients agree to participate/how many patients are approached for participation) and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants. | After approach for enrollment, an average of 3 weeks after starting radiation therapy |
| Adherence | The completion of cognitive training sessions is defined as completion of four out of five planned sessions. The rate of completion of cognitive training sessions and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants, and separately for virtual reality and iPad administration groups. | At the completion of radiation therapy, an average of 6 weeks after enrollment |
| Side Effects | Summary statistics, including counts and percentages of side effects/cyber sickness symptoms will be provided at pre-, immediate-, and 1-hour post-cognitive training for participants completing training via the iPad or virtual reality. | At the completion of radiation therapy, an average of 6 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Neurobehavioral | To estimate the effect size of change in cognitive outcomes associated with cognitive training in the virtual reality setting relative to cognitive training on an iPad. The effect size of the change in cognitive outcomes is defined as the difference in group means/standard deviation (e.g., Cohen's d). The effect size will be calculated separately for change in cognitive outcomes for cognitive training in the virtual reality setting or on iPad. The effect size of the difference of the change between two groups will also be estimated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather Conklin, PhD | Contact | 888-226-4343 | referralinfo@stjude.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Heitzer, PhD, ABPP-CN | St. Jude Children's Research Hospital | Principal Investigator |
| Heather Conklin, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Recruiting | 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 |
| St. Jude Brain Tumor Studies |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Single Blind
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| Cognitive training via virtual reality | Other | Participants will complete five sessions of the Cogmed training program within virtual reality. Participants will complete sessions over the course of one to two weeks while on campus for radiotherapy. Each session will take place in the Psychology Clinic and consist of 15 to 20 minutes of Cogmed training. |
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| After completion of post-training assessment, an average of 8 weeks after enrollment |
| Cerebral Hemodynamics | To evaluate patterns of cortical activation (oxygenated hemoglobin response) pre- and post- cognitive training on the iPad and in the virtual reality setting. The effects of VR and iPad based cognitive training will be assessed by n-back and grid-based spatial working memory tasks in conjunction with fNIRS brain imaging of the prefrontal cortex. | After completion of post-training assessment, an average of 8 weeks after enrollment |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |