Clinical trial NCT05000905: Improving Cognition and Behavior in Pediatric Cancer Survivors Using a Novel Mindful Attention Training
Official title: A Pilot Study of Assessing and Improving Cognition and Real-World Behavior in Pediatric Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: Pediatric Cancer Survivor
Attention
Cognitive Control
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Proportion of participants who complete study
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Change in mean performance on a Continuous Performance Task (CPT) over time
timeFrame: Up to 8 weeks
Other outcomes:
measure: Change in sub-test scores on the Adaptive Cognitive Evaluation (ACE) neuropsychological battery
timeFrame: Up to 8 weeks
measure: Change in mean performance on a computerized Math Fluency Test
timeFrame: Up to 8 weeks
measure: Change in mean performance on a computerized Reading Fluency Test
timeFrame: Up to 8 weeks
measure: Change in mean scores on the Mindful Attention Awareness Scale (MAAS) over time
timeFrame: Up to 8 weeks
measure: Change in mean scores on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) over time
timeFrame: Up to 8 weeks
measure: Change in mean scores on a modified Insomnia Severity Index (ISI) Scale over time
timeFrame: Up to 8 weeks
measure: Change in mean scores on the Child Self-Control Rating Scale (parent rating) over time
timeFrame: Up to 8 weeks
measure: Change in mean performance on a Delay Discounting Task over time
timeFrame: Up to 8 weeks
Locations:
city: San Francisco
country: United States
facility: Univeristy of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joaquin Anguera, PhD
role: PRINCIPAL_INVESTIGATOR
References: