Improving Cognition and Behavior in Pediatric Cancer Survivors Using a Novel Mindful Attention Training

Not Applicable

Recruiting

• Conditions: Pediatric Cancer
• Interventions: Behavioral: Adaptive Attention Training; Behavioral: Questionnaires

• Registration Number: NCT05000905
• Lead Sponsor: University of California, San Francisco

Brief Summary

This pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors.

Detailed Description

Pediatric cancer survivors (PCS) often experience attentional difficulties that have downstream effects on their quality of life, academic achievement, and future occupational attainment. As such, the primary goal of this project is to examine the outcomes of a novel, mindful attention training in this population and assess the feasibility of recruitment, retention, and adherence. Specifically, PCS will be randomly assigned to one of two adaptive attention training groups ('Engage') and complete tasks on the device for up to 8 weeks. Participants will also complete pre- and post-training assessments of cognition and behavior.

An additional cohort of no-contact participants will be asked to complete the assessments at baseline and end of study only to assess the feasibility and reliability of the assessment measures. This cohort will be enrolled separately and not randomized.

The investigators hypothesize that completion of 'Engage' training for the randomized cohorts will result in enhanced attentional control beyond the active comparator group that extends to other aspects of cognition in PCS.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-11
• Study Start: 2023-03-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Age 7-17 at the time of enrollment.
2. Able to understand study procedures and to comply with them for the entire length of the study.
3. Ability of individual and legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
4. Normal or corrected-normal vision and hearing.
5. English language fluency (minor participant and parent/guardian).
6. Received radiation therapy to the brain or neck between age 7-17.
7. Patients not on current cancer-related treatment (except supportive care) or those on other current treatments that would not hinder study participation. Patients currently on cancer-related treatments will be discussed with the study team (co-PI Mueller).

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Exclusion Criteria

1. Contraindication to any study-related procedure or assessment.
2. Motor/perceptual difficulties that prevent computer or tablet use.
3. Current cancer-related treatments that would impact the ability to participate in the study (e.g., current inpatient chemotherapy or intrathecal chemotherapy). Patients on other current treatments will be discussed with the study team (co-PI, Dr. Mueller)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adaptive Attention Training	Questionnaires	Participants will complete approximately 15 hours of an at-home training on a novel adaptive attention training program ('Engage'), which will consist of completing thirty, 30-minute sessions over a total of 6-8 weeks.
No Contact Group (Not Randomized)	Questionnaires	An additional thirty participants will be enrolled separately (not randomized) into the no-contact group. Participants in the no-contact group will not complete any study activities for 6-8 weeks after completing the baseline assessments. After this period, participants will be prompted to log into Nexus to complete end of study assessments (same set of assessments administered/completed at baseline).
Low-dose Adaptive Attention Training	Questionnaires	Participants will complete approximately 1 hour of at-home training on 'Engage' which consists of two, 30-minute sessions at the beginning and middle of a 6-8 week period.
Low-dose Adaptive Attention Training	Adaptive Attention Training	Participants will complete approximately 1 hour of at-home training on 'Engage' which consists of two, 30-minute sessions at the beginning and middle of a 6-8 week period.
Adaptive Attention Training	Adaptive Attention Training	Participants will complete approximately 15 hours of an at-home training on a novel adaptive attention training program ('Engage'), which will consist of completing thirty, 30-minute sessions over a total of 6-8 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of participants who complete study	Up to 8 weeks	The proportion of participants who completed the study procedures will be reported by study cohort.

Secondary Outcome Measures

Name	Time	Method
Change in mean performance on a Continuous Performance Task (CPT) over time	Up to 8 weeks	The CPT is a 23-minute task, where participants are instructed to respond to target stimuli (squares at the top of the screen) and withhold responses to non-target stimuli (squares at the bottom of the screen). Performance will be quantified as: (1) mean reaction times, (2) standard deviation of reaction times (RTV), and (3) d-prime (comparing correct target detections or 'hits' to incorrect non-target detections or 'false alarms').

Trial Locations

Locations (1)

Univeristy of California, San Francisco; 🇺🇸 San Francisco, California, United States