NCT05528939 Feasibility/Acceptability of Attentional-Control Training in Survivors
| NCT ID | NCT05528939 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's National Research Institute |
| Condition | Pediatric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-06-14 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-06-14 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Aged 8-16 years at time of screening. * History of diagnosis of acute lymphoblastic leukemia (ALL) or brain tumor (BT). * At least 1 year from completion of planned therapy and stable from a disease standpoint. * Participating child and caregiver are fluent in spoken English. * Availability of a caregiver who is willing and capable of providing support and supervision during cognitive training. * 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. * Only patients with a T-score ≥ 75th percentile on the CPT-3 Omission Errors scale or on the BRIEF-2 Cognitive Regulation Index will be randomized. Exclusion Criteria: * A history of photosensitive seizures. * A motor, visual, or auditory handicap that prevents computer use. * A mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training. * 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.
Contact & Investigator
Steven Hardy, Ph.D.
PRINCIPAL INVESTIGATOR
Children's National Research Institute
Frequently Asked Questions
Who can join the NCT05528939 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 16 Years, studying Pediatric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05528939 currently recruiting?
Yes, NCT05528939 is actively recruiting participants. Contact the research team at sjhardy@childrensnational.org for enrollment information.
Where is the NCT05528939 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT05528939 clinical trial?
NCT05528939 is sponsored by Children's National Research Institute. The principal investigator is Steven Hardy, Ph.D. at Children's National Research Institute. The trial plans to enroll 50 participants.
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