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NCT Number: NCT05704790

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

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 weeks from trial entry

    Completion of Study Questionnaires, PKEQ, at time of enrollment at after intervention completion.

Other outcomes

  1. Study completion

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2023
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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