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Feasibility/Acceptability of Attentional-Control Training in Survivors

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 16 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 month
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be assigned to either the EndeavorRx intervention, which includes 25-30 minute sessions per day, 5 days per week, for one month, or an active control condition of the same duration and intensity."
  • "Patients will undergo neurocognitive testing pre- and post-intervention, and parents will complete questionnaires regarding their child's functioning."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests EndeavorRx, a program to train attention skills, in children ages 8–16 who have survived acute lymphoblastic leukemia or a brain tumor. It looks at whether the training is practical, whether families find it acceptable, and whether it may help. Children must have finished cancer treatment at least 1 year ago.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 8–16 years old when checked for the study.
  • Have had acute lymphoblastic leukemia (ALL), a blood cancer, or a brain tumor.
  • Have finished planned treatment at least 1 year ago and have stable cancer status.
  • Both the child and caregiver must speak English fluently.
  • Have a caregiver who can and will help and supervise during the training.
  • Take no prescribed stimulant medicine for attention problems, or have taken the same dose for at least 30 days before joining.
  • To be assigned to a study group by chance, score at or above the 75th percentile on either of two tests of attention or thinking skills (CPT-3 Omission Errors or BRIEF-2 Cognitive Regulation Index).

Who can't join

  • Have a history of seizures triggered by flashing lights.
  • Have movement, vision, or hearing problems that prevent computer use.
  • Have a mental health condition that prevents training or needs treatment before taking part.
  • Have an estimated overall IQ score below 80 on the study’s starting test (WASI-II). These children will not be assigned to a study group.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

DC