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Clinical Trials/NCT05704790
NCT05704790CompletedNot Applicable

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 enrollmentStarted: February 17, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
8 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Intervention

Experimental

The intervention will include 5 weekly sessions (60-90 minutes each) of cognitive compensatory training (CCT) delivered virtually by a pediatric neuropsychologist.

Intervention: Cognitive Compensatory Training (Other)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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