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

Pediatric Cancer Clinical Trial

Official title:

A Pilot Study of Assessing and Improving Cognition and Real-World Behavior in Pediatric Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000905
• Other study ID #: 210822
• Secondary ID: NCI-2022-07364
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Courtney Gallen, Ph.D.
• Phone: 877-827-3222
• Email: engage.pcs[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Behavioral:
• 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.
• Questionnaires
Computer based assessments measuring attention, memory, daily habits, and mental health

Locations

Country	Name	City	State
United States	Univeristy of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in sub-test scores on the Adaptive Cognitive Evaluation (ACE) neuropsychological battery	The ACE is a mobile cognitive assessment tool, which includes a battery of cognitive control tests for rapid tests of cognition. The sub-tests (or 'modules') in ACE are adapted from standardized tasks to rapidly assess various aspects of cognition, including attention, memory, and multitasking.	Up to 8 weeks
Other	Change in mean performance on a computerized Math Fluency Test	To assess math fluency, participants solve simple math problems (e.g., addition, subtraction, multiplication) over a 3-minute period. Performance is measured as the number of correct responses.	Up to 8 weeks
Other	Change in mean performance on a computerized Reading Fluency Test	To assess reading fluency, participants indicate whether sentences are 'True' or 'False' over a 3-minute period. Performance is measured as the number of correct responses.	Up to 8 weeks
Other	Change in mean scores on the Mindful Attention Awareness Scale (MAAS) over time	The MAAS is a 15-item scale designed to assess a core characteristic of mindfulness by asking participants to respond to statements about everyday experiences on a scale from 1="Almost always" to 6="Almost never". The total score is obtained by averaging the scores of the 15 items, to generate a total score for from 1-6. Greater scores are indicative of a greater level of mindfulness.	Up to 8 weeks
Other	Change in mean scores on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) over time	The 14-item scale WEMWBS addresses mental well-being by asking participants to respond to individual items on a scale from 1="None of the time" to 5="All of the time". The total score is obtained by summing the scores for each of the 14 items, to generate a total score ranging from 14-70. Lower scores are indicative of a lower overall well-being.	Up to 8 weeks
Other	Change in mean scores on a modified Insomnia Severity Index (ISI) Scale over time	The modified ISI consists of the first three of seven items in the full ISI scale. These three questions ask participants about the the severity of their insomnia symptoms on a scale from 0="None" to 4="Very". The total score is obtained by summing the scores for each of the three items, to generate a total score from 0-12. Higher scores are indicative of more insomnia problems.	Up to 8 weeks
Other	Change in mean scores on the Child Self-Control Rating Scale (parent rating) over time	The Child Self-Control Rating Scale consists of 33 items that assess children's self control. Parents respond to individual items on a 7-point scale. The total score is obtained by summing the scores for each of the 33 items, with a higher score reflecting greater lack of child self-control.	Up to 8 weeks
Other	Change in mean performance on a Delay Discounting Task over time	The Delay Discounting task is an untimed task, where participants choose between smaller, more immediate rewards and larger, more delayed rewards. Performance will be quantified by comparing choices between smaller/immediate rewards and larger/delayed rewards as the rate of delay discounting (the hyperbolic discounting index).	Up to 8 weeks
Primary	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	Change in mean performance on a Continuous Performance Task (CPT) over time	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').	Up to 8 weeks