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Clinical Trials/NCT05704790
NCT05704790
Active, Not Recruiting
N/A

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

University of Michigan Rogel Cancer Center1 site in 1 country26 target enrollmentFebruary 17, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Cancer
Sponsor
University of Michigan Rogel Cancer Center
Enrollment
26
Locations
1
Primary Endpoint
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
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2023
End Date
November 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 6 weeks from trial entry

Completion of Study Questionnaire, BRIEF-2, at time of enrollment at after intervention completion.

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

Time Frame: 6 weeks from trial entry

Completion of Study Questionnaire, Conners 3, at time of enrollment at after intervention completion.

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

Time Frame: 6 weeks from trial entry

Completion of Study Questionnaire, SMALSI-2, at time of enrollment at after intervention completion.

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

Time Frame: 6 weeks from trial entry

Completion of Study Questionnaires, SPSI-R , at time of enrollment at after intervention completion.

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

Time Frame: 6 weeks from trial entry

Completion of Study Questionnaires, PKEQ, at time of enrollment at after intervention completion.

Study Sites (1)

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