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Behavioral Intervention
Mindful Attention Training for Pediatric Cancer Survivors
N/A
Recruiting
Led By Joaquin Anguera, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal or corrected-normal vision and hearing
Age 7-17 at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new training to help with thinking and behavior in kids who have survived cancer.
Who is the study for?
This trial is for children aged 7-17 who have survived pediatric cancer, can follow the study's procedures, and have a guardian to consent. They should speak English fluently, not be on certain cancer treatments that affect participation, and must have had radiation therapy to the brain or neck.
What is being tested?
The study tests an adaptive attention training program against standard questionnaires to see if it improves thinking skills and behavior in kids who've beaten cancer. It's a pilot study which means it's preliminary research before larger studies.
What are the potential side effects?
Since this trial involves attention training exercises and questionnaires rather than medication, traditional side effects are not expected. However, participants may experience fatigue or frustration related to cognitive tasks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My vision and hearing are normal, or corrected to normal.
Select...
I am between 7 and 17 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants who complete study
Secondary study objectives
Change in mean performance on a Continuous Performance Task (CPT) over time
Other study objectives
Change in mean performance on a Delay Discounting Task over time
Change in mean performance on a computerized Math Fluency Test
Change in mean performance on a computerized Reading Fluency Test
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: No Contact Group (Not Randomized)Experimental Treatment1 Intervention
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).
Group II: Adaptive Attention TrainingExperimental Treatment2 Interventions
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.
Group III: Low-dose Adaptive Attention TrainingActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~4280
Adaptive Attention Training
2019
N/A
~60
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,106 Total Patients Enrolled
Joaquin Anguera, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
1,897 Total Patients Enrolled
Courtney L Gallen, Ph.D.Principal InvestigatorUniversity of California, San Francisco
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My vision and hearing are normal, or corrected to normal.I am between 7 and 17 years old.I, and if applicable, my legal guardian, can understand and are willing to sign the informed consent document.I am not on any cancer treatments that would affect this study, except for supportive care.I understand and can follow the study's procedures.I had radiation therapy to my brain or neck when I was between 7 and 17 years old.You have difficulty using a computer or tablet due to problems with moving or understanding things.
Research Study Groups:
This trial has the following groups:- Group 1: Adaptive Attention Training
- Group 2: Low-dose Adaptive Attention Training
- Group 3: No Contact Group (Not Randomized)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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