Pediatric CancerNCT05000905
Improving Cognition and Behavior in Pediatric Cancer Survivors Using a Novel Mindful Attention Training
A study testing Adaptive Attention Training and Questionnaires in people with Pediatric Cancer, run by University of California, San Francisco.
Trial summary
This pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Adaptive Attention Training and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 7-17 at the time of enrollment.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Ability of individual and legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- Normal or corrected-normal vision and hearing.
- English language fluency (minor participant and parent/guardian).
- Received radiation therapy to the brain or neck between age 7-17.
- Patients not on current cancer-related treatment (except supportive care) or those on other current treatments that would not hinder study participation. Patients currently on cancer-related treatments will be discussed with the study team (co-PI Mueller).
Who cannot join
- Contraindication to any study-related procedure or assessment.
- Motor/perceptual difficulties that prevent computer or tablet use.
- Current cancer-related treatments that would impact the ability to participate in the study (e.g., current inpatient chemotherapy or intrathecal chemotherapy). Patients on other current treatments will be discussed with the study team (co-PI, Dr. Mueller)
About this study
Official title: A Pilot Study of Assessing and Improving Cognition and Real-World Behavior in Pediatric Cancer Survivors
This pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors.
Read the detailed description
Pediatric cancer survivors (PCS) often experience attentional difficulties that have downstream effects on their quality of life, academic achievement, and future occupational attainment. As such, the primary goal of this project is to examine the outcomes of a novel, mindful attention training in this population and assess the feasibility of recruitment, retention, and adherence. Specifically, PCS will be randomly assigned to one of two adaptive attention training groups ('Engage') and complete tasks on the device for up to 8 weeks. Participants will also complete pre- and post-training assessments of cognition and behavior.
An additional cohort of no-contact participants will be asked to complete the assessments at baseline and end of study only to assess the feasibility and reliability of the assessment measures. This cohort will be enrolled separately and not randomized.
The investigators hypothesize that completion of 'Engage' training for the randomized cohorts will result in enhanced attentional control beyond the active comparator group that extends to other aspects of cognition in PCS.
- Conditions
- Pediatric Cancer
- Being tested
- Adaptive Attention Training, Questionnaires
- Keywords
- Pediatric Cancer Survivor, Attention, Cognitive Control
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Attention TrainingBehavioural
The training is comprised of a time-based titration of rich audiovisual and sparse audio interactive environments. Training progressively transitions the participants from an immersive and rapid reward setting to a less immersive, sensory impoverished, and slower reward setting. Further, the participants' actions require delayed gratification decisions to accomplish play in the sparse setting, building fronto-parietal control through sustained attention and suppression of ventral-striatal reward impulses.
QuestionnairesBehavioural
Computer based assessments measuring attention, memory, daily habits, and mental health
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Attention Training | Experimental | Participants will complete approximately 15 hours of an at-home training on a novel adaptive attention training program ('Engage'), which will consist of completing thirty, 30-minute sessions over a total of 6-8 weeks. Receives: Behavioral: Adaptive Attention Training; Behavioral: Questionnaires |
| Low-dose Adaptive Attention Training | Active comparator | Participants will complete approximately 1 hour of at-home training on 'Engage' which consists of two, 30-minute sessions at the beginning and middle of a 6-8 week period. Receives: Behavioral: Adaptive Attention Training; Behavioral: Questionnaires |
| No Contact Group (Not Randomized) | Other | An additional thirty participants will be enrolled separately (not randomized) into the no-contact group. Participants in the no-contact group will not complete any study activities for 6-8 weeks after completing the baseline assessments. After this period, participants will be prompted to log into Nexus to complete end of study assessments (same set of assessments administered/completed at baseline). Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who complete study
The proportion of participants who completed the study procedures will be reported by study cohort.
Measured: Up to 8 weeks
Secondary outcomes (1)
Change in mean performance on a Continuous Performance Task (CPT) over time
The CPT is a 23-minute task, where participants are instructed to respond to target stimuli (squares at the top of the screen) and withhold responses to non-target stimuli (squares at the bottom of the screen). Performance will be quantified as: (1) mean reaction times, (2) standard deviation of reaction times (RTV), and (3) d-prime (comparing correct target detections or 'hits' to incorrect non-target detections or 'false alarms').
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start20 Mar 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: Slow accrual
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 University of California, San FranciscoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquin Anguera, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000905
- Sponsor's protocol ID
- 210822
- Other IDs
- NCI-2022-07364
- Status last verified
- Jul 2025
- First submitted
- 9 Aug 2021
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Assessing and Improving Cognition and Real-World Behavior in Pediatric Cancer Survivors
- ClinicalTrials.gov ID
- NCT05000905
- Acronym / sponsor ID
- 210822
- Conditions
- Pediatric Cancer
- Keywords
- Pediatric Cancer Survivor, Attention, Cognitive Control
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 11 Aug 2021 (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 pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors.
Detailed description
Pediatric cancer survivors (PCS) often experience attentional difficulties that have downstream effects on their quality of life, academic achievement, and future occupational attainment. As such, the primary goal of this project is to examine the outcomes of a novel, mindful attention training in this population and assess the feasibility of recruitment, retention, and adherence. Specifically, PCS will be randomly assigned to one of two adaptive attention training groups ('Engage') and complete tasks on the device for up to 8 weeks. Participants will also complete pre- and post-training assessments of cognition and behavior.
An additional cohort of no-contact participants will be asked to complete the assessments at baseline and end of study only to assess the feasibility and reliability of the assessment measures. This cohort will be enrolled separately and not randomized.
The investigators hypothesize that completion of 'Engage' training for the randomized cohorts will result in enhanced attentional control beyond the active comparator group that extends to other aspects of cognition in PCS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adaptive Attention Training | Experimental | Behavioral: Adaptive Attention Training, Behavioral: QuestionnairesParticipants will complete approximately 15 hours of an at-home training on a novel adaptive attention training program ('Engage'), which will consist of completing thirty, 30-minute sessions over a total of 6-8 weeks. |
| Low-dose Adaptive Attention Training | Active comparator | Behavioral: Adaptive Attention Training, Behavioral: QuestionnairesParticipants will complete approximately 1 hour of at-home training on 'Engage' which consists of two, 30-minute sessions at the beginning and middle of a 6-8 week period. |
| No Contact Group (Not Randomized) | Other | Behavioral: QuestionnairesAn additional thirty participants will be enrolled separately (not randomized) into the no-contact group. Participants in the no-contact group will not complete any study activities for 6-8 weeks after completing the baseline assessments. After this period, participants will be prompted to log into Nexus to complete end of study assessments (same set of assessments administered/completed at baseline). |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 7-17 at the time of enrollment.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Ability of individual and legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- Normal or corrected-normal vision and hearing.
- English language fluency (minor participant and parent/guardian).
Key exclusion criteria (3 listed)
- Contraindication to any study-related procedure or assessment.
- Motor/perceptual difficulties that prevent computer or tablet use.
- Current cancer-related treatments that would impact the ability to participate in the study (e.g., current inpatient chemotherapy or intrathecal chemotherapy). Patients on other current treatments will be discussed with the study team (co-PI, Dr. Mueller)
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 |
|---|---|---|
| Adaptive Attention TrainingThe training is comprised of a time-based titration of rich audiovisual and sparse audio interactive environments. Training progressively transitions the participants from an immersive and rapid reward setting to a less immersive, sensory impoverished, and slower reward setting. Further, the participants' actions require delayed gratification decisions to accomplish play in the sparse setting, building fronto-parietal control through sustained attention and suppression of ventral-striatal reward impulses. | Behavioural | Adaptive Attention Training, Low-dose Adaptive Attention Training |
| QuestionnairesComputer based assessments measuring attention, memory, daily habits, and mental health | Behavioural | Adaptive Attention Training, Low-dose Adaptive Attention Training, No Contact Group (Not Randomized) |
Primary outcome
Proportion of participants who complete study
Time frame: Up to 8 weeks
The proportion of participants who completed the study procedures will be reported by study cohort.
1 secondary outcome
Change in mean performance on a Continuous Performance Task (CPT) over time
Time frame: Up to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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. This study is not recruiting at the moment.
Joaquin Anguera, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Attention Training and Questionnaires in people with Pediatric Cancer, run by University of California, San Francisco.
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 3 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: withdrawn, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who complete study (time frame: Up to 8 weeks). 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 6 Aug 2025.