Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01503086 |
|
Recruitment Status :
Recruiting
First Posted : January 2, 2012
Last Update Posted : January 31, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Neoplasm Recurrent Brain Neoplasm | Procedure: Cognitive Assessment Other: Computer-Assisted Cognitive Training Procedure: Psychosocial Assessment and Care Other: Quality-of-Life Assessment Other: Questionnaire Administration | Not Applicable |
PRIMARY OBJECTIVES:
I. To assess the feasibility of a home-based, computerized, cognitive training program for patients with pediatric brain tumors who are undergoing cranial radiation therapy (CRT), treated in multiple Children Oncology Group (COG) institutions.
EXPLORATORY OBJECTIVES:
I. To estimate the effect size of this program on measures of attention and working memory in patients with brain tumors treated with CRT in order to design a definitive large-scale clinical trial.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (intervention): Patients undergo a home-based, computerized, interactive training program comprising 3-5 sessions of 15-45 minutes every week for 5-9 weeks. The program contains twelve visually engaging and interesting exercises that target skills involving visual-spatial and verbal working memory (WM). The program is adaptive in a way that each difficulty task is automatically adjusted on a trial-by-trail basis to match a patient's current WM. Each patient has an interventional coach who has online access to patient's training sessions and outcomes (pass or fail). Coaches are able to modify the training sequence or make suggestions to patients and/or parents about how progress can be maximized. Coaches also have telephone meetings with patients and/or families once a week to ensure compliance, track progress, provide feedback, and answer questions that arise during training.
ARM II (control): Patients undergo a home-based, computerized, interactive, non-adaptive training program comprising 3-5 sessions of 15-45 minutes a week for 5-9 weeks. Each patient also has an interventional coach as in arm I. Patients in both arms complete a brief neuropsychological/behavioral assessment comprising the Wechsler Intelligence Scale for Children (WIS-IV), the Children's Memory Scale (CMS), and the California Verbal Learning Test-Children's Version (CVLT-C) at baseline, after completion of study, and at 6 months after completion of study. Additionally, parents complete a parent-report questionnaire to gather information about patient's behaviors, thoughts, emotions, adaptive skills, and social and functional impairment. Parents and children also complete surveys about the program regarding technical feasibility, adherence, ease-of-use, and satisfaction.
After completion of study treatment, participants are followed up within 3 weeks, then at 6 months.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 71 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study |
| Actual Study Start Date : | November 18, 2013 |
| Estimated Primary Completion Date : | March 30, 2027 |
| Estimated Study Completion Date : | March 30, 2027 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Arm I (interactive training program)
Patients undergo a home-based, computerized, interactive training program comprising 3-5 sessions of 15-45 minutes every week for 5-9 weeks. The program contains twelve visually engaging and interesting exercises that target skills involving visual-spatial and verbal WM. The program is adaptive in a way that each difficulty task is automatically adjusted on a trial-by-trail basis to match a patient's current WM. Each patient has an interventional coach who has online access to patient's training sessions and outcomes (pass or fail). Coaches are able to modify the training sequence or make suggestions to patients and/or parents about how progress can be maximized. Coaches also have telephone meetings with patients and/or families once a week to ensure compliance, track progress, provide feedback, and answer questions that arise during training.
|
Procedure: Cognitive Assessment
Ancillary studies Other: Computer-Assisted Cognitive Training Receive computer-assisted cognitive training Procedure: Psychosocial Assessment and Care Ancillary studies
Other Name: Psychosocial Care/Assessment Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
|
Experimental: Arm II (non-adaptive training program)
Patients undergo a home-based, computerized, interactive, non-adaptive training program comprising 3-5 sessions of 15-45 minutes a week for 5-9 weeks. Each patient also has an interventional coach as in arm I. Patients in both arms complete a brief neuropsychological/behavioral assessment comprising the WIS-IV, the CMS, and the CVLT-C at baseline, after completion of study, and at 6 months after completion of study. Additionally, parents complete a parent-report questionnaire to gather information about patient's behaviors, thoughts, emotions, adaptive skills, and social and functional impairment. Parents and children also complete surveys about the program regarding technical feasibility, adherence, ease-of-use, and satisfaction.
|
Procedure: Cognitive Assessment
Ancillary studies Other: Computer-Assisted Cognitive Training Receive computer-assisted cognitive training Procedure: Psychosocial Assessment and Care Ancillary studies
Other Name: Psychosocial Care/Assessment Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
- Proportion of patients with intervention compliance [ Time Frame: Up to 9 weeks of starting training ]Intervention compliance defined as at least 80% of sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training).
- Parent-rated executive function using the Metacognition subscales from the Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- Working memory (WM) using the Metacognition subscales from (BRIEF) [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- Executive function using the Groton Maze Learning task of the CogState battery [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- WM by the one-back task from CogState [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- WM by Digit Span from Wechsler Intelligence Scales [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- Visual working memory using Spatial Span from Wechsler Scale [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- Visual memory using Dot Location from Children's Memory Scale [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- Technical feasibility based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- Adherence based on total number of training sessions completed [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- Satisfaction based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
- Ease of use based on the item responses to the 13-item Feasibility Interview [ Time Frame: Up to 6 months post training completion ]Descriptive/summary statistics will be provided.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Patient must be newly diagnosed or relapsed/progressed with a brain tumor that has not previously been treated with CRT
- Note: COG therapeutic study participation is not required for ACCL10P1 enrollment
-
Patient enrollment must occur within 4 calendar months following completion of CRT
- Reminder: after patient enrollment, baseline testing followed by randomization must occur within 2-4 months after completion of CRT
- The patient must have an identified caregiver who is willing and able to oversee the training practice during the intervention period (ie, for 5-9 weeks starting approximately 3 months after completion of CRT)
- The patient must have access to a telephone and phone number where they can be reached
- The patient and caregiver must have reading, speaking and listening comprehension of English
- All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution's policy)
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with pontine glioma are not eligible
- Patients with an estimated survival of less than one year are not eligible
- Patients with a history of traumatic brain injury prior to tumor diagnosis are not eligible
- Patients with a motor, visual, or auditory handicap that prevents computer use (e.g., unresolved posterior fossa syndrome) are not eligible to participate in this trial
- Patients with full-scale intelligence quotient (IQ) < 70 per previous testing OR existing diagnosis of/educational classification as a student with an intellectual disability are not eligible
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503086
Show 28 study locations
| Principal Investigator: | Kristina K Hardy | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01503086 |
| Other Study ID Numbers: |
ACCL10P1 NCI-2012-00112 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-ACCL10P1 CDR0000721387 ACCL10P1 ( Other Identifier: Children's Oncology Group ) COG-ACCL10P1 ( Other Identifier: DCP ) ACCL10P1 ( Other Identifier: CTEP ) U10CA095861 ( U.S. NIH Grant/Contract ) UG1CA189955 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 2, 2012 Key Record Dates |
| Last Update Posted: | January 31, 2023 |
| Last Verified: | August 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
|
Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |