Clinical trial NCT05704790: Feasibility and Acceptability of Brief, Telehealth Cognitive Compensatory Training for Pediatric Cancer Patients
Official title: Feasibility and Acceptability of Brief, Telehealth Cognitive Compensatory Training for Children Treated for Pediatric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: 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
timeFrame: 6 weeks from trial entry
measure: 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
timeFrame: 6 weeks from trial entry
measure: 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
timeFrame: 6 weeks from trial entry
measure: 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
timeFrame: 6 weeks from trial entry
measure: 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
timeFrame: 6 weeks from trial entry
Secondary outcomes:
Other outcomes:
measure: Study completion
timeFrame: 6 weeks from trial entry
measure: Clinical outcomes based off of response to the BRIEF-2 study questionnaire
timeFrame: 6 weeks from trial entry
measure: Clinical outcomes based off of response to the Conners 3 study questionnaire
timeFrame: 6 weeks from trial entry
measure: Clinical outcomes based off of response to the SMALSI-2 study questionnaire
timeFrame: 6 weeks from trial entry
measure: Clinical outcomes based off of response to the SPSI-R study questionnaire
timeFrame: 6 weeks from trial entry
measure: Clinical outcomes based off of response to the PKEQ study questionnaire
timeFrame: 6 weeks from trial entry
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Kaitlin McCloskey
role: PRINCIPAL_INVESTIGATOR
References: