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

NCT ID: NCT05000905

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2025-05-31

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.

Conditions

Pediatric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Adaptive Attention Training

Intervention Type: BEHAVIORAL

The training is comprised of a time-based titration of rich audiovisual and sparse audio interactive environments. Training progressively transitions the participants from an immersive and rapid reward setting to a less immersive, sensory impoverished, and slower reward setting. Further, the participants' actions require delayed gratification decisions to accomplish play in the sparse setting, building fronto-parietal control through sustained attention and suppression of ventral-striatal reward impulses.

Questionnaires

Intervention Type: BEHAVIORAL

Computer based assessments measuring attention, memory, daily habits, and mental health

Low-dose 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.

Group Type: ACTIVE_COMPARATOR

Adaptive Attention Training

Intervention Type: BEHAVIORAL

The training is comprised of a time-based titration of rich audiovisual and sparse audio interactive environments. Training progressively transitions the participants from an immersive and rapid reward setting to a less immersive, sensory impoverished, and slower reward setting. Further, the participants' actions require delayed gratification decisions to accomplish play in the sparse setting, building fronto-parietal control through sustained attention and suppression of ventral-striatal reward impulses.

Questionnaires

Intervention Type: BEHAVIORAL

Computer based assessments measuring attention, memory, daily habits, and mental health

No Contact Group (Not Randomized)

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).

Group Type: OTHER

Questionnaires

Intervention Type: BEHAVIORAL

Computer based assessments measuring attention, memory, daily habits, and mental health

Interventions

Adaptive Attention Training

The training is comprised of a time-based titration of rich audiovisual and sparse audio interactive environments. Training progressively transitions the participants from an immersive and rapid reward setting to a less immersive, sensory impoverished, and slower reward setting. Further, the participants' actions require delayed gratification decisions to accomplish play in the sparse setting, building fronto-parietal control through sustained attention and suppression of ventral-striatal reward impulses.

Intervention Type: BEHAVIORAL

Questionnaires

Computer based assessments measuring attention, memory, daily habits, and mental health

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joaquin Anguera, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

NCI-2022-07364

Identifier Type: REGISTRY

Identifier Source: secondary_id

210822

Identifier Type: -

Identifier Source: org_study_id