Pediatric CancerFAACTSNCT05528939
Feasibility/Acceptability of Attentional-Control Training in Survivors
A study testing EndeavorRx in people with Pediatric Cancer and Pediatric ALL, run by Children's National Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Pediatric Cancer, Pediatric ALL, Pediatric Brain Tumor
- What is being tested?
- EndeavorRx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Steven Hardy, PhD, 202-476-5000, sjhardy@childrensnational.org
About this study
Official title: FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors
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.
Read the detailed description
Survival rates are increasing for common pediatric cancers, including acute lymphoblastic leukemia (ALL) and brain tumors; yet, the life-saving treatments for these cancers place survivors at heightened risk for sustained cognitive effects. Longitudinal research has shown that the cognitive burden of ALL and pediatric brain tumors often consists of impairments in attention, working memory, and executive functioning, which can result in long-term disruption to daily living, socialization, academic achievement, and quality of life. Few non-pharmacological interventions exist to ameliorate these cognitive late effects. EndeavorRx, an FDA-approved electronic attentional-control training program, may be one intervention to help remediate executive functioning difficulties experienced by survivors. Although the program has been efficacious for youth with Attention-Deficit/Hyperactivity Disorder (ADHD), it has not yet been tested among survivors of childhood ALL or brain tumor. We propose to assess the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a pilot randomized, controlled trial. Survivors of ALL or brain tumor who are between the ages of 8 and 16 and have been off-therapy for at least one year will be included. The goal is to enroll and screen approximately 50 survivors across three pediatric oncology centers, in order to identify 40 participants with attention difficulties who will be randomized to one of two treatment arms. 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. It is hypothesized that this attentional-control training program will be both acceptable and feasible, with sufficient enrollment, positive satisfaction ratings, and acceptable treatment adherence. It is also anticipated that participants will show increases in performance-based and parent-rated attention, as compared to those in the active control condition.
- Conditions
- Pediatric Cancer, Pediatric ALL, Pediatric Brain Tumor, Attention Difficulties, Cognitive Deficit in Attention
- Being tested
- EndeavorRx, Control video game
- Medical subject headings
- Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndeavorRxDevice
EndeavorRx is a digital intervention delivered through an action video game that is indicated to improve attention function. EndeavorRx users first complete two discrete tasks: 1) a perceptual discrimination/attention task in which users respond to target stimuli and ignore distractor stimuli (e.g., tapping the screen quickly only when red aliens appear) and 2) a sensorimotor navigation task in which users tilt their device to steer a hovercraft down a river while targeting or avoiding certain objects. Users are subsequently presented with a multitask training session where they complete the perceptual discrimination/attention task and the sensorimotor navigation task simultaneously. Algorithms adapt the program in both real-time and between sessions to automatically adjust the difficulty level.
Control video gameOther
The active control program, used in previous studies of this intervention, was designed to match EndeavorRx on expectancy, engagement, and time on task in the form of a challenging and engaging digital word game, targeting cognitive domains not targeted by EndeavorRx and not primarily associated with attentional difficulties. Users are instructed to find and connect letters on a grid to spell words; points are awarded based on number of words formed, word length, and the use of unusual letters. There is progression in difficulty to maintain engagement and expectation of benefit from patients and their caregivers.
| Study group | Role | What they receive |
|---|---|---|
| EndeavorRx | Experimental | Children will be asked to begin digital attentional control training at home within 6 weeks of baseline testing and to complete 6 training missions per day (25-30 minutes), 5 days per week, for 4 weeks (total = 120 training missions). Receives: Device: EndeavorRx |
| Control | Active comparator | An active control program designed to replicate aspects of the intervention (e.g., regular use of digital device to access fun educational activities) while engaging cognitive skills not particularly involving attention. Receives: Other: Control video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by patient/family interest
Feasibility will be determined by examining the proportion of eligible patients/families approached about the study who enroll
Measured: Baseline
Feasibility assessed by EndeavorRx training adherence rates
Participants will be asked to complete 6 EndeavorRx training missions per day, 5 days per week, for 4 weeks, resulting in a possible training of 120 missions. Feasibility will be evaluated by examining the proportion of the sample that completes at least 60 EndeavorRx missions (50%).
Measured: After completion of 4 weeks of EndeavorRx training
Feasibility assessed by reports of technical ease-of-use and satisfaction
Children and caregivers will be asked, "How easy or difficult was it to access (e.g., turn on device, start the program, use the program)" using a 5-point Likert scale (5 = "Very Easy"). Families will also be asked, "How satisfied or unsatisfied are you with your experience using EndeavorRx?" using a 5-point Likert scale (5 = "Very Satisfied").
Measured: End of training (+4 weeks)
Secondary outcomes (8)
Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at end of training
The Conners CPT-3 is a standardized computer-administered assessment that uses T scores (M=50, SD=10) where higher scores indicate greater attention problems
Measured: Baseline and end of training (+4 weeks)
Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)
The Conners CPT-3 is a standardized computer-administered assessment that uses T scores (M=50, SD=10) where higher scores indicate greater attention problems
Measured: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at end of training
The ADHD-RS-5 is a caregiver-reported questionnaire measure of attentional symptoms based on DSM-5 criteria where higher raw scores indicate greater attention problems
Measured: Baseline and end of training (+4 weeks)
Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)
The ADHD-RS-5 is a caregiver-reported questionnaire measure of attentional symptoms based on DSM-5 criteria where higher raw scores indicate greater attention problems
Measured: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
Change from baseline inhibitory control assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Inhibit subscale at end of training
The BRIEF-2 is a caregiver-reported questionnaire measure of executive functioning that uses T scores (M=50, SD=10) where higher scores indicate greater problems with executive functioning
Measured: Baseline and end of training (+4 weeks)
Change from baseline inhibitory control assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Inhibit subscale at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)
The BRIEF-2 is a caregiver-reported questionnaire measure of executive functioning that uses T scores (M=50, SD=10) where higher scores indicate greater problems with executive functioning
Measured: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
Change from baseline executive functioning assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Cognitive Regulation Index (CRI) at end of training
The BRIEF-2 is a caregiver-reported questionnaire measure of executive functioning that uses T scores (M=50, SD=10) where higher scores indicate greater problems with executive functioning
Measured: Baseline and end of training (+4 weeks)
Change from baseline executive functioning assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Cognitive Regulation Index (CRI) at end of training
The BRIEF-2 is a caregiver-reported questionnaire measure of executive functioning that uses T scores (M=50, SD=10) where higher scores indicate greater problems with executive functioning
Measured: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start14 Jun 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, randomized, active-control trial using a 1:1 randomization (stratified by diagnosis) to the intervention or a comparison digital activity.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- St. Jude Children's Research Hospital, Children's Hospital of Philadelphia, George Washington University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Steven J. Hardy, Children's National Research Institute
- Investigators
- Steven Hardy, Ph.D., Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528939
- Sponsor's protocol ID
- STUDY00000150
- Other IDs
- R21CA261877
- Acronym
- FAACTS
- Status last verified
- Jan 2025
- First submitted
- 1 Sep 2022
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors
- ClinicalTrials.gov ID
- NCT05528939
- Acronym / sponsor ID
- FAACTS / STUDY00000150
- Conditions
- Pediatric Cancer, Pediatric ALL, Pediatric Brain Tumor, Attention Difficulties, Cognitive Deficit in Attention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- St. Jude Children's Research Hospital, Children's Hospital of Philadelphia, George Washington University, National Cancer Institute (NCI)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Survival rates are increasing for common pediatric cancers, including acute lymphoblastic leukemia (ALL) and brain tumors; yet, the life-saving treatments for these cancers place survivors at heightened risk for sustained cognitive effects. Longitudinal research has shown that the cognitive burden of ALL and pediatric brain tumors often consists of impairments in attention, working memory, and executive functioning, which can result in long-term disruption to daily living, socialization, academic achievement, and quality of life. Few non-pharmacological interventions exist to ameliorate these cognitive late effects. EndeavorRx, an FDA-approved electronic attentional-control training program, may be one intervention to help remediate executive functioning difficulties experienced by survivors. Although the program has been efficacious for youth with Attention-Deficit/Hyperactivity Disorder (ADHD), it has not yet been tested among survivors of childhood ALL or brain tumor. We propose to assess the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a pilot randomized, controlled trial. Survivors of ALL or brain tumor who are between the ages of 8 and 16 and have been off-therapy for at least one year will be included. The goal is to enroll and screen approximately 50 survivors across three pediatric oncology centers, in order to identify 40 participants with attention difficulties who will be randomized to one of two treatment arms. 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. It is hypothesized that this attentional-control training program will be both acceptable and feasible, with sufficient enrollment, positive satisfaction ratings, and acceptable treatment adherence. It is also anticipated that participants will show increases in performance-based and parent-rated attention, as compared to those in the active control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, randomized, active-control trial using a 1:1 randomization (stratified by diagnosis) to the intervention or a comparison digital activity.
| Arm | Type | Receives |
|---|---|---|
| EndeavorRx | Experimental | Device: EndeavorRxChildren will be asked to begin digital attentional control training at home within 6 weeks of baseline testing and to complete 6 training missions per day (25-30 minutes), 5 days per week, for 4 weeks (total = 120 training missions). |
| Control | Active comparator | Other: Control video gameAn active control program designed to replicate aspects of the intervention (e.g., regular use of digital device to access fun educational activities) while engaging cognitive skills not particularly involving attention. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndeavorRxEndeavorRx is a digital intervention delivered through an action video game that is indicated to improve attention function. EndeavorRx users first complete two discrete tasks: 1) a perceptual discrimination/attention task in which users respond to target stimuli and ignore distractor stimuli (e.g., tapping the screen quickly only when red aliens appear) and 2) a sensorimotor navigation task in which users tilt their device to steer a hovercraft down a river while targeting or avoiding certain objects. Users are subsequently presented with a multitask training session where they complete the perceptual discrimination/attention task and the sensorimotor navigation task simultaneously. Algorithms adapt the program in both real-time and between sessions to automatically adjust the difficulty level. | Device | EndeavorRx |
| Control video gameThe active control program, used in previous studies of this intervention, was designed to match EndeavorRx on expectancy, engagement, and time on task in the form of a challenging and engaging digital word game, targeting cognitive domains not targeted by EndeavorRx and not primarily associated with attentional difficulties. Users are instructed to find and connect letters on a grid to spell words; points are awarded based on number of words formed, word length, and the use of unusual letters. There is progression in difficulty to maintain engagement and expectation of benefit from patients and their caregivers. | Other | Control |
Primary outcome
Feasibility assessed by patient/family interest
Time frame: Baseline
Feasibility will be determined by examining the proportion of eligible patients/families approached about the study who enroll
Feasibility assessed by EndeavorRx training adherence rates
Time frame: After completion of 4 weeks of EndeavorRx training
Participants will be asked to complete 6 EndeavorRx training missions per day, 5 days per week, for 4 weeks, resulting in a possible training of 120 missions. Feasibility will be evaluated by examining the proportion of the sample that completes at least 60 EndeavorRx missions (50%).
Feasibility assessed by reports of technical ease-of-use and satisfaction
Time frame: End of training (+4 weeks)
Children and caregivers will be asked, "How easy or difficult was it to access (e.g., turn on device, start the program, use the program)" using a 5-point Likert scale (5 = "Very Easy"). Families will also be asked, "How satisfied or unsatisfied are you with your experience using EndeavorRx?" using a 5-point Likert scale (5 = "Very Satisfied").
8 secondary outcomes
Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at end of training
Time frame: Baseline and end of training (+4 weeks)
Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)
Time frame: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at end of training
Time frame: Baseline and end of training (+4 weeks)
Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)
Time frame: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
Change from baseline inhibitory control assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Inhibit subscale at end of training
Time frame: Baseline and end of training (+4 weeks)
Change from baseline inhibitory control assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Inhibit subscale at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)
Time frame: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
Change from baseline executive functioning assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Cognitive Regulation Index (CRI) at end of training
Time frame: Baseline and end of training (+4 weeks)
Change from baseline executive functioning assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Cognitive Regulation Index (CRI) at end of training
Time frame: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Hardy, Ph.D. principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndeavorRx in people with Pediatric Cancer and Pediatric ALL, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Hardy, Ph.D. (202-476-5000, sjhardy@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by patient/family interest (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.