Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia (NCT02336282) | Clinical Trial Compass
CompletedNot Applicable
Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
United States53 participantsStarted 2015-01-12
Plain-language summary
A common and potentially debilitating late effect of childhood cancer treatment is neurocognitive impairment, frequently in the domain of executive dysfunction, which can limit educational attainment, employment, and quality of life. Among the survivors of childhood acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of executive function impairment has been shown as high as 58.8%, with moderate to severe impairment as high as 33.5%, and risk for impairment increased with time from diagnosis. Given the potential of pervasive impact of neurocognitive impairment on daily life, interventions directed at reducing neurocognitive dysfunction among childhood cancer survivors with long-term follow-up are needed. This study examines the potential feasibility and efficacy of a novel intervention to improve executive function.
Primary Objectives:
* To evaluate the feasibility of a home-based intervention using Transcranial Direct Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).
Secondary Objectives:
* To estimate the efficacy of a tDCS intervention paired with cognitive training.
* To explore the short-term effect of tDCS on measures of executive function among adult survivors of childhood ALL participating in the SJLIFE protocol
Who can participate
Age range
18 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:
* Current St. Jude LIFE (SJLIFE) Protocol Participant
* Long term survivor of acute lymphoblastic leukemia (ALL)
* Currently ≥ 18 years of age
* Wi-Fi internet access at home
* History of executive dysfunction, documented by neurocognitive testing, and defined as having an age-adjusted standard score \<20th percentile on Trail Making Test Part B, Verbal Fluency, or Digit Span Backward.
* History of self-reported executive dysfunction in daily life, defined as having a standardized score \<20th percentile on BRIEF Initiate, Shift, or Working Memory domains OR having scored \<20th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire Task Efficiency or Memory domains.
* Participant is able to speak and understand the English language.
Exclusion Criteria:
* Any survivor with full scale intelligence quotient (IQ) \<80
* Currently on stimulants or other medications intended to treat cognitive impairment
* History of seizures
* No implanted medical devices or implanted metal in the head
* Currently pregnant or planning to become pregnant.
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
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.