Feasibility and Acceptability of Brief, Telehealth Cognitive Compensatory Training for Pediatric Cancer Patients

Study Overview
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Brief Summary
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This pilot study will be a prospective, single arm study to investigate the feasibility and acceptability of a brief, telehealth, cognitive compensatory training intervention for children with a history of pediatric cancer at the University of Michigan. Study aims to enroll 10 children with a history of treatment for pediatric cancer, along with their caregiver.

Official Title
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Feasibility and Acceptability of Brief, Telehealth Cognitive Compensatory Training for Children Treated for Pediatric Cancer

Conditions
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Pediatric Cancer

Intervention / Treatment
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* Other: Cognitive Compensatory Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient between the ages of 8 and 18 Patient has a history of pediatric cancer Patient is at least 6 months posttreatment completion Patient and caregiver are fluent in English, as intervention materials are only available in English at this time. Patient demonstrates deficits in attention and/or executive functioning as evidenced by either (a) performance below one standard deviation on at least one cognitive measure of attention or executive functioning, such as on the Conners Continuous Performance Test (CPT-3), Trail making Test A & B, Children's Category Test (CCT), and Wisconsin Card Sorting Test (WCST) and/or (b) executive functioning and attention problems are identified during screening with the research assistant. Exclusion Criteria: Patient has a history of treatment for a pediatric brain tumor Patient has a history of traumatic brain injury or seizures Patient has a history of a developmental disorder (i.e., autism, intellectual disability), behavioral disorder (i.e., oppositional defiant disorder, conduct disorder), or mood disorder (i.e., disruptive mood dysregulation disorder) that would negatively interfere with patient's participation in the intervention.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention will include 5 weekly sessions (60-90 minutes each) of cognitive compensatory training (CCT) delivered virtually by a pediatric neuropsychologist. | Other: Cognitive Compensatory Training<br>* The intervention will include 5 weekly sessions (60-90 minutes each) of cognitive compensatory training (CCT) delivered virtually by a pediatric neuropsychologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining satisfaction and perceived benefit from study intervention based off of change in results from the BRIEF-2 questionnaire from baseline to 6 weeks post trial entry | Completion of Study Questionnaire, BRIEF-2, at time of enrollment at after intervention completion. | 6 weeks from trial entry | 
| Determining satisfaction and perceived benefit from study intervention based off of change in results from the Conners 3 questionnaire from baseline to 6 weeks post trial entry | Completion of Study Questionnaire, Conners 3, at time of enrollment at after intervention completion. | 6 weeks from trial entry | 
| Determining satisfaction and perceived benefit from study intervention based off of change in results from the SMALSI-2 questionnaire from baseline to 6 weeks post trial entry | Completion of Study Questionnaire, SMALSI-2, at time of enrollment at after intervention completion. | 6 weeks from trial entry | 
| Determining satisfaction and perceived benefit from study intervention based off of change in results from the SPSI-R questionnaire from baseline to 6 weeks post trial entry | Completion of Study Questionnaires, SPSI-R , at time of enrollment at after intervention completion. | 6 weeks from trial entry | 
| Determining satisfaction and perceived benefit from study intervention based off of change in results from the PKEQ questionnaire from baseline to 6 weeks post trial entry | Completion of Study Questionnaires, PKEQ, at time of enrollment at after intervention completion. | 6 weeks from trial entry |