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

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ClinicalTrials.gov Identifier: NCT05000905
Recruitment Status : Not yet recruiting
First Posted : August 11, 2021
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 9, 2021
First Posted Date  ICMJE August 11, 2021
Last Update Posted Date August 11, 2021
Estimated Study Start Date  ICMJE January 1, 2022
Estimated Primary Completion Date March 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2021)
Change in mean performance on a Continuous Performance Task (CPT) over time [ Time Frame: 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').
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2021)
Change in mean performance on a Delay Discounting Task over time [ Time Frame: Up to 8 weeks ]
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 9, 2021)
  • Change in sub-test scores on the Adaptive Cognitive Evaluation (ACE) neuropsychological battery [ Time Frame: Up to 8 weeks ]
    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.
  • Change in mean performance on a computerized Math Fluency Test [ Time Frame: Up to 8 weeks ]
    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.
  • Change in mean performance on a computerized Reading Fluency Test [ Time Frame: Up to 8 weeks ]
    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.
  • Change in mean scores on the Mindful Attention Awareness Scale (MAAS) over time [ Time Frame: Up to 8 weeks ]
    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.
  • Change in mean scores on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) over time [ Time Frame: Up to 8 weeks ]
    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.
  • Change in mean scores on a modified Insomnia Severity Index (ISI) Scale over time [ Time Frame: Up to 8 weeks ]
    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.
  • Change in mean scores on the Child Self-Control Rating Scale (parent rating) over time [ Time Frame: Up to 8 weeks ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving Cognition and Behavior in Pediatric Cancer Survivors Using a Novel Mindful Attention Training
Official Title  ICMJE A Pilot Study of Assessing and Improving Cognition and Real-World Behavior in Pediatric Cancer Survivors
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. 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. The investigators hypothesize that completion of 'Engage' training will result in enhanced attentional control beyond the active comparator group that extends to other aspects of cognition in PCS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pediatric Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Adaptive Attention Training
  • Active Comparator: 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.
    Intervention: Behavioral: Adaptive Attention Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 9, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2024
Estimated Primary Completion Date March 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have received radiation therapy to the brain or neck
  • Age 7-17 years at the time of radiation therapy
  • Survival >1 year after diagnosis
  • Currently not undergoing treatment

Exclusion Criteria:

  • Not native English speaking
  • Motor or perceptual disability that prevents computer or tablet use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Courtney L Gallen, Ph.D. 415-502-7322 courtney.gallen@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05000905
Other Study ID Numbers  ICMJE 21-34653
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Courtney L Gallen, Ph.D. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP