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

NCT05000905 | Withdrawn

• 2 other identifiers: 210822NCI-2022-07364
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pediatric Cancer

Keywords

Pediatric Cancer Survivor; Attention; Cognitive Control

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who complete study

  The proportion of participants who completed the study procedures will be reported by study cohort.

  Up to 8 weeks

Secondary Outcomes (1)

• Change in mean performance on a Continuous Performance Task (CPT) over time

  Up to 8 weeks

Other Outcomes (8)

• Change in sub-test scores on the Adaptive Cognitive Evaluation (ACE) neuropsychological battery

  Up to 8 weeks

• Change in mean performance on a computerized Math Fluency Test

  Up to 8 weeks

• Change in mean performance on a computerized Reading Fluency Test

  Up to 8 weeks

Study Arms (3)

Adaptive Attention Training

EXPERIMENTAL

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.

Behavioral: Adaptive Attention Training; Behavioral: Questionnaires

Low-dose Adaptive Attention Training

ACTIVE COMPARATOR

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.

Behavioral: Adaptive Attention Training; Behavioral: Questionnaires

No Contact Group (Not Randomized)

OTHER

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).

Behavioral: Questionnaires

Interventions

Adaptive Attention Training 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.

Adaptive Attention Training; Low-dose Adaptive Attention Training

Questionnaires BEHAVIORAL

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

Adaptive Attention Training; Low-dose Adaptive Attention Training; No Contact Group (Not Randomized)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 7-17 at the time of enrollment.
• Able to understand study procedures and to comply with them for the entire length of the study.
• Ability of individual and legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
• Normal or corrected-normal vision and hearing.
• English language fluency (minor participant and parent/guardian).
• Received radiation therapy to the brain or neck between age 7-17.
• 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).

You may not qualify if:

• Contraindication to any study-related procedure or assessment.
• Motor/perceptual difficulties that prevent computer or tablet use.
• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Joaquin Anguera, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Forty participants will be randomized to the Engage intervention (30-session) or low-dose (2-session). Individuals in each active arm will be matched on age and gender. An additional thirty participants will be enrolled separately (not randomized) into the no-contact group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 11, 2021
• Study Start: March 20, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share