RECRUITING

Feasibility/Acceptability of Attentional-Control Training in Survivors

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Conditions

Pediatric CancerPediatric ALLPediatric Brain TumorAttention DifficultiesCognitive Deficit in Attention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter pilot randomized controlled trial, with an active control condition, of the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a cohort of survivors of acute lymphoblastic leukemia or brain tumor ages 8-16 who are \> 1 year from the end of therapy.

Official Title

FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors

Quick Facts

Study Start:2023-06-14
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05528939

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Aged 8-16 years at time of screening.
  2. * History of diagnosis of acute lymphoblastic leukemia (ALL) or brain tumor (BT).
  3. * At least 1 year from completion of planned therapy and stable from a disease standpoint.
  4. * Participating child and caregiver are fluent in spoken English.
  5. * Availability of a caregiver who is willing and capable of providing support and supervision during cognitive training.
  6. * Participating child is either not taking any prescribed stimulant medication for attention difficulties or has been prescribed a stable dose of stimulant medication for attention difficulties for at least 30 days prior to enrollment.
  7. * Only patients with a T-score \> 57 (i.e., ≥75th percentile) for Omission Errors on the CPT-3 will be randomized.
  1. * A history of photosensitive seizures.
  2. * A motor, visual, or auditory handicap that prevents computer use.
  3. * A mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training.
  4. * Participants identified during the baseline assessment as having a full-scale IQ \< 80, as estimated by WASI-II (Vocabulary and Matrix Reasoning), will not be randomized.

Contacts and Locations

Study Contact

Steven Hardy, Ph.D.
CONTACT
202-476-5000
sjhardy@childrensnational.org

Principal Investigator

Steven Hardy, Ph.D.
PRINCIPAL_INVESTIGATOR
Children's National Research Institute

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

  • Steven Hardy, Ph.D., PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-14
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-06-14
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pediatric Cancer
  • Pediatric ALL
  • Pediatric Brain Tumor
  • Attention Difficulties
  • Cognitive Deficit in Attention