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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05704790
Enrollment
26
Registered
2023-01-30
Start date
2023-02-17
Completion date
2024-07-25
Last updated
2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer

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.

Interventions

OTHERCognitive Compensatory Training

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

Sponsors

University of Michigan Rogel Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
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 entry6 weeks from trial entryCompletion 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 entry6 weeks from trial entryCompletion 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 entry6 weeks from trial entryCompletion 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 entry6 weeks from trial entryCompletion 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 entry6 weeks from trial entryCompletion of Study Questionnaires, PKEQ, at time of enrollment at after intervention completion.

Other

MeasureTime frameDescription
Study completion6 weeks from trial entryPossible factors contributing to study completion will be gathered from the History Questionnaire
Clinical outcomes based off of response to the PKEQ study questionnaire6 weeks from trial entryClinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the PKEQ questionnaire
Clinical outcomes based off of response to the BRIEF-2 study questionnaire6 weeks from trial entryClinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the BRIEF-2 questionnaire
Clinical outcomes based off of response to the Conners 3 study questionnaire6 weeks from trial entryClinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the Conners 3 questionnaire
Clinical outcomes based off of response to the SMALSI-2 study questionnaire6 weeks from trial entryClinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the SMALSI-2 questionnaire
Clinical outcomes based off of response to the SPSI-R study questionnaire6 weeks from trial entryClinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the SPSI-R questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026