Feasibility/Acceptability of Attentional-Control Training in Survivors (NCT05528939) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility/Acceptability of Attentional-Control Training in Survivors
United States50 participantsStarted 2023-06-14
Plain-language 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.
Who can participate
Age range
8 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility assessed by patient/family interest
Timeframe: Baseline
2
Feasibility assessed by EndeavorRx training adherence rates
Timeframe: After completion of 4 weeks of EndeavorRx training
3
Feasibility assessed by reports of technical ease-of-use and satisfaction