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.

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.

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).

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.

Adaptive Attention Training

Computer based assessments measuring attention, memory, daily habits, and mental health

Questionnaires

Courtney Gallen, Ph.D.

Courtney L Gallen, PhD

Joaquin A Anguera, PhD

Sabine Mueller, MD, PhD

Courtney L Gallen, Ph.D.

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

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.

Forty participants will be randomized to the Engage intervention (30-session) or low-dose (2-session). Individuals in each active arm will be matched on age and gender.

An additional thirty participants will be enrolled separately (not randomized) into the no-contact group.

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

A Pilot Study of Assessing and Improving Cognition and Real-World Behavior in Pediatric Cancer Survivors

The ACE is a mobile cognitive assessment tool, which includes a battery of cognitive control tests for rapid tests of cognition. The sub-tests (or 'modules') in ACE are adapted from standardized tasks to rapidly assess various aspects of cognition, including attention, memory, and multitasking.

To assess math fluency, participants solve simple math problems (e.g., addition, subtraction, multiplication) over a 3-minute period. Performance is measured as the number of correct responses.

To assess reading fluency, participants indicate whether sentences are 'True' or 'False' over a 3-minute period. Performance is measured as the number of correct responses.

The MAAS is a 15-item scale designed to assess a core characteristic of mindfulness by asking participants to respond to statements about everyday experiences on a scale from 1="Almost always" to 6="Almost never". The total score is obtained by averaging the scores of the 15 items, to generate a total score for from 1-6. Greater scores are indicative of a greater level of mindfulness.

The 14-item scale WEMWBS addresses mental well-being by asking participants to respond to individual items on a scale from 1="None of the time" to 5="All of the time". The total score is obtained by summing the scores for each of the 14 items, to generate a total score ranging from 14-70. Lower scores are indicative of a lower overall well-being.

The modified ISI consists of the first three of seven items in the full ISI scale. These three questions ask participants about the the severity of their insomnia symptoms on a scale from 0="None" to 4="Very". The total score is obtained by summing the scores for each of the three items, to generate a total score from 0-12. Higher scores are indicative of more insomnia problems.

The Child Self-Control Rating Scale consists of 33 items that assess children's self control. Parents respond to individual items on a 7-point scale. The total score is obtained by summing the scores for each of the 33 items, with a higher score reflecting greater lack of child self-control.

The Delay Discounting task is an untimed task, where participants choose between smaller, more immediate rewards and larger, more delayed rewards. Performance will be quantified by comparing choices between smaller/immediate rewards and larger/delayed rewards as the rate of delay discounting (the hyperbolic discounting index).

The proportion of participants who completed the study procedures will be reported by study cohort.

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').

University of California, San Francisco

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

All Drugs and Chemicals

Hormones

Patients will have a Blood sample taken to check hormone levels. Patients will also have an ultrasound test done to examine the ovaries. The ultrasound test is done by inserting a cylindrical probe into the vagina. The test has to be done this way to measures the ovaries accurately.

Blood Draw and Ultrasound

David Hodgson, MD

Chemotherapy can damage the ovaries and cause premature menopause. In women treated before the age of 40 years, menopause does not usually occur. We have very little information about the impact of chemotherapy on ovarian function in this particular group of women. In this study, we will check hormone blood tests and ultrasound tests of the ovaries to measure the reserve of eggs left in the ovaries after treatment in young survivors of breast cancer and childhood cancer. We will do the same tests in our comparison group. We can use these results to estimate the reduction in fertility in young cancer survivors.

As women across North America and Europe increasingly delay childbirth, fertility preservation is emerging as an important issue among young breast cancer patients. The dramatic increase in survival for the major pediatric cancers in the last 50 years has resulted in an expanding population of childhood cancer survivors. The information currently available to counsel these patients about the impact of treatment on their fertility is inadequate. A significant degree of subfertility can exist prior to the onset of frank ovarian failure, and current studies do not address this.

This study will adopt new technologies that have revolutionized the evaluation of female fertility to assess ovarian function in young breast cancer survivors. The results will provide new, more accurate and clinically useful information to patients and physicians about the impact of cancer therapy on fertility. The results have the potential to influence clinical decisions regarding cancer treatment, and the use of assisted reproductive technologies for contemporary patients and survivors. Further, insofar as treatment advances are designed to improve disease control while reducing toxicity, these results may serve as the basis for better understanding the toxicity of modern therapy and provide opportunities for improvement.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Cognition and Behavior in Pediatric Cancer Survivors Using a Novel Mindful Attention Training	NCT05000905	Pediatric Cance...	Adaptive Attent... Questionnaires	7 Years - 17 Years	University of California, San Francisco
Improving Cognition and Behavior in Pediatric Cancer Survivors Using a Novel Mindful Attention Training	NCT05000905	Pediatric Cance...	Adaptive Attent... Questionnaires	7 Years - 17 Years	University of California, San Francisco
Assessment of Ovarian Reserve in Female Cancer Survivors	NCT01062542	Breast Cancer S... Pediatric Cance...	Blood Draw and ...	18 Years - 50 Years	University Health Network, Toronto

Spots Global Cancer Trial Database for pediatric cancer survivor