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Behavioural Intervention

Game-Based Therapy for Attention Skills in Pediatric Cancer Survivors (FAACTS Trial)

N/A

Recruiting

Led By Steven Hardy, Ph.D.

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of training (+4 weeks)

Awards & highlights

FAACTS Trial Summary

This trial tests a new game-based therapy for kids recovering from cancer to help them improve their attention skills.

Who is the study for?

This trial is for children aged 8-16 who survived acute lymphoblastic leukemia or brain tumor, are more than a year post-treatment, and have attention difficulties. They must speak English and have caregiver support. Kids on stable ADHD meds can join; those with certain disabilities, seizures, low IQ, or prioritized mental health conditions cannot.Check my eligibility

What is being tested?

The study tests the feasibility and initial effectiveness of a game called EndeavorRx designed to improve attention in pediatric cancer survivors against a control video game. It's a multi-center pilot study where participants are randomly assigned to either the test game or an active control condition.See study design

What are the potential side effects?

Since this trial involves cognitive training games rather than medication, traditional side effects like you'd see with drugs aren't expected. However, there may be risks associated with screen time or frustration from gameplay.

FAACTS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and end of training (+4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and end of training (+4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and end of training (+4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility assessed by EndeavorRx training adherence rates

Feasibility assessed by patient/family interest

Feasibility assessed by reports of technical ease-of-use and satisfaction

Secondary outcome measures

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

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)

Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at end of training

+4 more

FAACTS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EndeavorRxExperimental Treatment1 Intervention

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).

Group II: ControlActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

George Washington UniversityOTHER

243 Previous Clinical Trials

453,724 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,391 Total Patients Enrolled

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,582,970 Total Patients Enrolled

Media Library

EndeavorRx (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05528939 — N/A

Attention Deficit Disorder Research Study Groups: EndeavorRx, Control

Attention Deficit Disorder Clinical Trial 2023: EndeavorRx Highlights & Side Effects. Trial Name: NCT05528939 — N/A

EndeavorRx (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05528939 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can potentially join this clinical trial?

"Affirmative, the data hosted on clinicaltrials.gov suggests that this medical study is currently recruiting and was first posted June 14th 2023. The trial requires 50 participants to be recruited from 1 site before completion."

Answered by AI

Does the clinical trial stipulate an age limit, and if so, does it include people over 85?

"Prospective participants for this trial must meet the age criteria of 8 to 16 years old. There are 112 studies available for those under 18, and 597 trials dedicated towards seniors over 65."

Answered by AI

Is this study currently seeking participants?

"Per the information available on clinicaltrials.gov, this trial is in search of suitable participants and was first posted on June 14th 2023 with its latest edit being on June 23rd 2023."

Answered by AI

Who meets the eligibility criteria for this research trial?

"This clinical examination is open to 50 children between 8-16 years of age with acute lymphoblastic leukemia. Candidates should be proficient in spoken English, have finished their prescribed therapy one year ago and remain disease free since then, as well as having a T-score greater than 57 (75th percentile) for Omission Errors on the CPT-3. Caregivers must also be available and capable of providing assistance during cognitive training sessions, and if patients are taking stimulants for attention difficulties, they must have been on a stable dosage for at least 30 days prior to enrollment."

Answered by AI

What is the ultimate aim of this clinical experiment?

"This trial's primary outcome, which will be evaluated during a pre-defined timeline is the Adherence rates of EndeavorRx training. Secondary outcomes include Change from baseline inattention measured by Omission Errors on Conners' Continuous Performance Test 3rd edition (CPT-3) at 16 weeks post intervention (+/- 4 weeks). The CPT-3 gives T scores (M = 50, SD = 10), where higher scores equate to more attention deficits; as well as changes from beginning levels of Attentional symptoms using DSM-5 criteria through ADHD Rating Scale 5th Edition Inattention subscale both at end of study"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility/Acceptability of Attentional-Control Training in Survivors

Steven J. Hardy 2023. "Feasibility/Acceptability of Attentional-Control Training in Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05528939.

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