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

NCT05704790 | Completed

• 2 other identifiers: UMCC 2022.068HUM00218780
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Study completion

  6 weeks from trial entry

• Clinical outcomes based off of response to the BRIEF-2 study questionnaire

  6 weeks from trial entry

• Clinical outcomes based off of response to the Conners 3 study questionnaire

  6 weeks from trial entry

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Cognitive Compensatory Training OTHER

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

Intervention

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kaitlin McCloskey

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 30, 2023
• Study Start: February 17, 2023
• Primary Completion: July 23, 2024
• Study Completion: July 25, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)