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

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 Overview

• Status: Recruiting
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: Cognitive Compensatory Training

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cancer AnswerLine; Phone Number: 1-800-865-1125; Email: CancerAnswerLine@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Cancer AnswerLine; Phone Number: 800-865-1125; Email: CancerAnswerLine@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention will include 5 weekly sessions (60-90 minutes each) of cognitive compensatory training (CCT) delivered virtually by a pediatric neuropsychologist.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Completion of Study Questionnaire, BRIEF-2, at time of enrollment at after intervention completion.	6 weeks from trial entry
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	Completion of Study Questionnaire, Conners 3, at time of enrollment at after intervention completion.	6 weeks from trial entry
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	Completion of Study Questionnaire, SMALSI-2, at time of enrollment at after intervention completion.	6 weeks from trial entry
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	Completion of Study Questionnaires, SPSI-R , at time of enrollment at after intervention completion.	6 weeks from trial entry
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	Completion of Study Questionnaires, PKEQ, at time of enrollment at after intervention completion.	6 weeks from trial entry

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study completion	Possible factors contributing to study completion will be gathered from the History Questionnaire	6 weeks from trial entry
Clinical outcomes based off of response to the BRIEF-2 study questionnaire	Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the BRIEF-2 questionnaire	6 weeks from trial entry
Clinical outcomes based off of response to the Conners 3 study questionnaire	Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the Conners 3 questionnaire	6 weeks from trial entry
Clinical outcomes based off of response to the SMALSI-2 study questionnaire	Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the SMALSI-2 questionnaire	6 weeks from trial entry
Clinical outcomes based off of response to the SPSI-R study questionnaire	Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the SPSI-R questionnaire	6 weeks from trial entry
Clinical outcomes based off of response to the PKEQ study questionnaire	Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the PKEQ questionnaire	6 weeks from trial entry

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Kaitlin McCloskey, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: UMCC 2022.068; HUM00218780 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: PI does not plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No