Improving Cognition and Behavior in Pediatric Cancer Survivors Using a Novel Mindful Attention Training

University of California San Francisco (UCSF)

Status: Withdrawn

Conditions: Pediatric Cancer

Treatments: Behavioral: Questionnaires; Behavioral: Adaptive Attention Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05000905

210822 (Other Identifier)

NCI-2022-07364 (Registry Identifier)

Details and patient eligibility

About

This pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors.

Full 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.

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 7-17 at the time of enrollment.
2. Able to understand study procedures and to comply with them for the entire length of the study.
3. Ability of individual and legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
4. Normal or corrected-normal vision and hearing.
5. English language fluency (minor participant and parent/guardian).
6. Received radiation therapy to the brain or neck between age 7-17.
7. 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).

Exclusion criteria

1. Contraindication to any study-related procedure or assessment.
2. Motor/perceptual difficulties that prevent computer or tablet use.
3. 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

Adaptive Attention Training

Experimental group

Description:

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.

Treatment:

Behavioral: Adaptive Attention Training

Behavioral: Questionnaires

Low-dose Adaptive Attention Training

Active Comparator group

Description:

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:

Behavioral: Adaptive Attention Training

Behavioral: Questionnaires

No Contact Group (Not Randomized)

Other group

Description:

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).

Treatment:

Behavioral: Questionnaires