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

Not Applicable

Active, not recruiting

• Conditions: Pediatric Cancer
• Interventions: Other: Cognitive Compensatory Training

• Registration Number: NCT05704790
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-02-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-18
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	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	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	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	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	6 weeks from trial entry	Completion of Study Questionnaires, PKEQ, at time of enrollment at after intervention completion.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States