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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704790
• Other study ID #: UMCC 2022.068
• Secondary ID: HUM00218780
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Cancer AnswerLine
• Phone: 1-800-865-1125
• Email: CancerAnswerLine[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study completion	Possible factors contributing to study completion will be gathered from the History Questionnaire	6 weeks from trial entry
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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