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

Sponsor
University of Michigan Rogel Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05704790
Collaborator
(none)
20
1
1
12
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive Compensatory Training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Feasibility and Acceptability of Brief, Telehealth Cognitive Compensatory Training for Children Treated for Pediatric Cancer
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other Outcome Measures

  1. Study completion [6 weeks from trial entry]

    Possible factors contributing to study completion will be gathered from the History Questionnaire

  2. Clinical outcomes based off of response to the BRIEF-2 study questionnaire [6 weeks from trial entry]

    Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the BRIEF-2 questionnaire

  3. Clinical outcomes based off of response to the Conners 3 study questionnaire [6 weeks from trial entry]

    Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the Conners 3 questionnaire

  4. Clinical outcomes based off of response to the SMALSI-2 study questionnaire [6 weeks from trial entry]

    Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the SMALSI-2 questionnaire

  5. Clinical outcomes based off of response to the SPSI-R study questionnaire [6 weeks from trial entry]

    Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the SPSI-R questionnaire

  6. Clinical outcomes based off of response to the PKEQ study questionnaire [6 weeks from trial entry]

    Clinical outcomes of the intervention will also be summarized using empirically validated caregiver and child responses to the PKEQ questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 18 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan Rogel Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier:
NCT05704790
Other Study ID Numbers:
  • UMCC 2022.068
  • HUM00218780
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 30, 2023