Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Lymphosarcoma

Remotely delivered active tDCS + cognitive training

Remotely delivered sham tDCS + cognitive training

Participants will receive active 1mA direct current stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.

Active tDCS

Participants will receive sham (no direct current) stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.

Sham tDCS

Tara Brinkman, PhD

Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the area of executive functioning. Relatively limited research has focused on interventions for improving neurocognitive outcomes in long-term survivors of ALL. A promising technique for cognitive enhancement is Transcranial Direct Current Stimulation (tDCS) which differs from conventional cognitive remediation approaches in that it directly stimulates specific brain regions responsible for cognitive processes and activates functional networks similar to those activated during cognitive training.

Primary Objective

To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on direct testing of executive function in survivors of ALL.

Secondary Objectives

* To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on patient-reported symptoms of executive dysfunction in survivors of ALL.
* To examine the effects of home-based tDCS paired with remote cognitive training on patterns of regional brain activation as measured by functional magnetic resonance imaging.
* To examine the effects of home-based tDCS paired with remote cognitive training on white matter integrity and structure as measured by diffusion tensor imaging.

Eligible participants will be randomized to receive 1 mA direct current stimulation over the left dorsolateral prefrontal cortex or placebo/sham for 20 minutes. All participants will receive home-based computerized cognitive training. Participants will complete tDCS paired with cognitive training 2 times per week for 6-months.

Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

Digit Span Backward: Digit Span Backward (DSB), from the Digit Span subtest on the WAIS-IV, is a measure of working memory. The number of digits recalled in the longest span is converted to a standard z-score using age-based norms (Mean=0, SD=1).

Trail Making Test Part B (Trails B): This is a timed task that requires a participant to shift his/her attention adaptively and flexibly. Age-based standardized z-scores are calculated (Mean=0, SD=1).

Controlled Oral Word Association (COWA): This is a task of cognitive/verbal fluency that measures spontaneous production of words beginning with a designated letter or category. Age-based standardized z-scores are calculated (Mean=0, SD=1).

Patient reported symptoms of executive dysfunction will be evaluated via the Childhood Cancer Survivor Study Neurocognitive Questionnaire (CCSS-NCQ). The CCSS-NCQ is a 32-item questionnaire evaluating 4 domains of executive function. Z-scores (M=0, SD=1) are calculated using sibling data from the Childhood Cancer Survivor Study.

Patient reported symptoms of executive dysfunction will be evaluated via the Behavior Rating Inventory for Executive Function - Adult Version (BRIEF-A). The BRIEF-A is a 75-item measure of executive function that provides age- and sex-specific national normative data for nine domains of executive function (T-Score, M=50, SD=10).

White connectivity will be measured via diffusion tensor imaging and resting state fMRI (rsFMRI). The cortex will be parcellated into anatomical regions based on the high-resolution T1-weighted imaging using the FreeSurfer software (http://surfer.nmr.mgh.harvard.edu/). Probabilistic fiber tracking will be performed for individual seed points within the gray matter/white matter surface for each parcellated cortical region to evaluate strength of the connectivity between each individual region and every other region. The current project will focus analyses on the frontostriatal connections from the DLPFC to the striatum. rsfMRI data will be used to construct functional connectomes for each participant at each time point. We will measure several common connectome properties including global and local efficiency. Connectome modularity, degree distribution, and hub characteristics will also be measured.

Regional brain activation will be assessed using an N-Back Task. This task requires a participant to respond to a presented stimulus only when it is the same as one presented on a trial at a predetermined number prior to the current trial. For this study, we plan to use 1-back and 2-back trials. Improved efficiency will be defined as reduced activation in dorsolateral prefrontal cortex during performance on the N-Back task during the fMRI. Using Statistical Parametric Mapping software (SPM12, Wellcome Trust Centre for Neuroimaging, London), contrast-images from the fixed-effect analysis in each subject will be used for second level random-effect analysis to create group activation maps. These contrasts include pre- v. post-intervention imaging during the N-back task. Participants assigned to active stimulation will then be contrasted to those assigned to sham stimulation.

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

women with Stage I or II BC who

1. have undergone surgical treatment (biopsy, lumpectomy or mastectomy) and;
2. will be receiving adjuvant chemotherapy

Women with stage I or II BC who

1. Have undergone surgical treatment (biopsy, lumpectomy or mastectomy) \\
2. will not be receiving adjuvant chemotherapy

healthy education-age-matched women without cancer

Neurocognitive impairment observation

Mary Jo Grapp, PhD

This longitudinal project will investigate a common complaint of women who receive chemotherapy for breast cancer- cognitive difficulty. The relationships of fatigue, stress, and depression to cognitive difficulties will be examined. The findings should lead to interventions to decrease the effects of these problematic side effects.

Most women with breast cancer are diagnosed in the early stages of the disease (Stage I and II) and 90% of these can expect to survive at least 5 years. Adjuvant chemotherapy regimens for breast cancer are often associated with complaints of cognitive changes, mostly the inability to concentrate and memory lapses that may persist in some women long after chemotherapy has ended. These changes are frequently accompanied by reports of a triad of behavioral conditions: fatigue, increased stress, and depressive symptoms. Biologically, cytokine release patterns play an important role in regulation of the immune system and normal CNS function, including neural cell repair and metabolism of neurotransmitters-both critical for normal cognitive functioning. Thus, the theoretical underpinnings of this research are embedded in the biobehavioral (mind-body) model which characterizes the multidimensional interactions among the mind, neuroendocrine, and immune systems. The purpose of this prospective, longitudinal project of 100 women is to determine whether there are differences in cognitive functioning and related behavioral conditions (fatigue, perceived stress, and depressive symptoms) in women in each of 3 groups: those with early stage BC treated with surgery and chemotherapy, women with early stage BC treated with surgery and without chemotherapy and an age-gender-education-matched healthy cohort without cancer. The primary aim of the project is to examine the relationships among fatigue, perceived stress, and depressive symptoms and neurocognitive impairment. A secondary aim is to explore the relationships among key behavioral and biological markers that may explain underlying mechanisms for development of neurocognitive impairment. In particular, this project will explore pro- and anti-inflammatory cytokine patterns and their potential associations with neurocognitive functioning. For the primary aim, the mixed linear model will be used to test for differences between the groups. For analysis of the secondary aim variable reduction stage and correlation will be used. The strength of this project is its biobehavioral approach to discerning underlying mechanisms of neurocognitive impairment in women with early stage BC receiving adjuvant chemotherapy. In addition, three other common behavioral conditions associated with BC and/or chemotherapy, fatigue, perceived stress, and depressive symptoms, will be evaluated for their potentially confounding effects on cognitive function.

3 cc of blood in a BD Vacutainer® tube preserved with 5.4mg K2 EDTA for the cytokine assay

Examining a Common Complaint of Women Who Receive Chemotherapy for Breast Cancer- Cognitive Difficulty

Neurocognitive Impairment in Women With Early Stage Breast Cancer

National Institute of Nursing Research (NINR)

Virginia Commonwealth University

Nervous System Diseases

Symptoms and General Pathology

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Participants will receive a direct link to access the SHUTi program (per randomization) from the study team.

Participants will receive a direct link to access online patient education (per randomization) from the study team.

SHUTi is a fully automated, interactive and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is presented in six "Cores," metered out over time.

Sleep Healthy Using the Internet (SHUTi) Intervention Group

The online PE program provides static information about: insomnia symptoms; the impact, prevalence, and causes of insomnia; when to see a doctor; and basic lifestyle, environmental, and behavioral strategies to improve sleep.

Online Patient Education (PE) Control Group

There is evidence that survivors of childhood cancer have a high prevalence of poor sleep, including symptoms of insomnia. Insomnia is highly comorbid and has been associated with impaired cognitive performance, a range of psychiatric disorders, cardiovascular disease, and reduced quality of life. However, we still lack knowledge about the direct impact of available internet-based insomnia treatment programs for survivors of childhood cancer experiencing insomnia, in addition to how improving insomnia symptoms impacts neurocognitive function and late health morbidities in this population. Therefore, in this study, we will utilize the resources available in the Childhood Cancer Survivor Study (CCSS) to use an accepted, established, efficacious internet-delivered CBTi insomnia treatment program and evaluate the efficacy of this program in adult survivors of childhood cancer. Positive results from this study and our use of an internet-based intervention are likely generalizable and be scalable to the large and geographically diverse population of childhood cancer survivors with chronic health conditions.

Primary Objective

To examine the efficacy of an eHealth intervention for improving symptoms of insomnia among adult survivors of childhood cancer.

Secondary Objectives

To examine the impact of an eHealth intervention for insomnia on the clinical severity of insomnia symptoms in adult survivors of childhood cancer.

To determine whether treatment of insomnia symptoms will improve neurocognitive function in adult survivors of childhood cancer with both insomnia and neurocognitive impairment.

To explore the mediating effects of improved neurocognitive function, emotional distress, and cardiovascular health on the association between insomnia symptoms and quality of life.

Participants with clinically significant insomnia and neurocognitive impairment are eligible for the current study. Participants will complete a 9-week internet-based insomnia treatment program (SHUTi) or receive sleep education, depending on randomized group assignment. Participants will complete home-based assessments at 3 time points (baseline, post-intervention, 6 months). These assessments will include online questionnaires measuring insomnia symptoms, neurocognitive problems, fatigue, daytime sleepiness, and health related quality of life. In addition, at each time point participants will be asked to wear an activity monitor for one week to measure physical activity and sleep patterns. Each assessment time point will also include a home visit from Examination Management Services Inc (EMSI) to measure blood pressure, heart rate, cardiovascular biomarkers, and neurocognitive function.

eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer

eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer: A Randomized Clinical Trial

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request

This is a 7-item, Likert scale, self-report questionnaire assessing perception of sleep and consequences of insomnia. The scores range from 0 to 28 with higher values indicating increasing symptom burden.

The CCSS-NCQ was developed specifically to address neurocognitive concerns of adult survivors of childhood cancer and includes assessment of problems with memory, task efficiency, organization, and emotional regulation. T-scores are calculated using sibling normative data (Mean= 50, SD=10) with higher scores indicating worse problems.

This is a computerized assessment that measures 3 domains of cognitive function; Executive Function, Processing Speed and Working Memory. Age, sex, and race specific T-Scores (M=50, SD=10) are calculated. Higher scores indicate better functioning.

An online diary and will be included in the SHUTi program (including the patient education arm). The sleep dairy will assess daily sleep behaviors (e.g. time in bed, sleep onset latency, nighttime awakenings, sleep quality).

This questionnaire measures symptoms of depression. Scores range from 0 to 27 with higher scores indicating more severe symptoms.

This questionnaire measures symptoms of anxiety with scores ranging from 0 to 21. Higher scores indicate greater symptoms of anxiety.

This questionnaire measures general health-related quality of life. T-scores are calculated (M=50, SD=10) with higher scores indicated better quality of life.

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Melatonin

Antioxidants

Protective Agents

Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.

Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.

Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.

melatonin

Placebo tablets to match the melatonin will be comprised of inert substances.

placebo

Primary objective:

1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer.

Secondary objectives:

1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors.
2. To investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors.

This study is a randomized double-blind placebo controlled trial of time release melatonin for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning and/or difficulty falling asleep.

All participants undergo a general neurocognitive evaluation at baseline and 6-month follow-up, focused on assessment of intelligence, academic skills, attention, processing speed, memory and executive functions.

Sleep parameters using self-report and actigraphy will be assessed at three time points during the study: Baseline, 3-months, and 6-months.

Participants will be divided into 3 mutually exclusive groups:

* Cohort 1: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes less than once a week during the past month.
* Cohort 2: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes at least once a week during the past month.
* Cohort 3: Participant is absent of neurocognitive impairment defined as performance \>10th percentile on all six measures of attention, memory, and executive functioning, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes \> once a week during the past month.

Within each group, participants will be randomly assigned to take either 3 mgs of time release melatonin or placebo 1-2 hours before bedtime each night for 6 months.

Psychosocial measures of health-related quality of life and psychological distress will be completed at baseline and following 6 months of melatonin/placebo treatment.

Biological samples for serum melatonin levels will be collected at baseline and at the 6 month follow-up evaluation.

Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort

Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.

Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.

Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson's R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved.

Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.

melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.

Melatonin: NI Without DSOL

Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.

placebo: Placebo tablets to match the melatonin will be comprised of inert substances.

Placebo: NI Without DSOL

Melatonin: NI With DSOL

Placebo: NI With DSOL

Melatonin: No NI With DSOL

Placebo: No NI With DSOL

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment.

Tara M. Brinkman, PhD

Auditory Attention Difference

Sustained Attention Difference

Working Memory Difference

Long-term Verbal Memory Difference

Cognitive Flexibility

Cognitive Fluency Difference

Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.

Sleep onset latency - actigraphy

Sleet onset latency - self-report

Analysis based on intent to treat. Includes participants who were randomized and completed the 6-month assessment.

Sleep Onset Latency as Measured by Actigraphy and Self-report.

Data by participant actigraphy. Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.

melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.

Melatonin: NI With DSOL (Actigraphy)

Data by participant self-report. Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.

melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.

Melatonin: NI With DSOL (Self-report)

Analysis based on intent to treat includes Cohort 2 participants randomized to melatonin who completed the 6-month assessment. Cohorts 1 and 3 were not assessed. 2 assessments of the primary outcome collected in Cohort 2 included self-report and actigraphy. 50 is the total number with actigraphy data. Data were missing for 12 participants.

Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)	NCT04007601	Acute Lymphobla...	Active tDCS Sham tDCS	18 Years - 39 Years	St. Jude Children's Research Hospital
Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)	NCT04007601	Acute Lymphobla...	Active tDCS Sham tDCS	18 Years - 39 Years	St. Jude Children's Research Hospital
Examining a Common Complaint of Women Who Receive Chemotherapy for Breast Cancer- Cognitive Difficulty	NCT01553097	Breast Cancer Neurocognitive ... Quality of Life	Neurocognitive ...	21 Years -	Virginia Commonwealth University
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer	NCT04317742	Childhood Cance... Insomnia Neurocognitive ... Survivorship Late Effect Sleep	Sleep Healthy U... Online Patient ...	18 Years - 65 Years	St. Jude Children's Research Hospital
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort	NCT01700959	Cancer Malignan...	melatonin placebo	18 Years -	St. Jude Children's Research Hospital
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort	NCT01700959	Cancer Malignan...	melatonin placebo	18 Years -	St. Jude Children's Research Hospital
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer	NCT04317742	Childhood Cance... Insomnia Neurocognitive ... Survivorship Late Effect Sleep	Sleep Healthy U... Online Patient ...	18 Years - 65 Years	St. Jude Children's Research Hospital
Examining a Common Complaint of Women Who Receive Chemotherapy for Breast Cancer- Cognitive Difficulty	NCT01553097	Breast Cancer Neurocognitive ... Quality of Life	Neurocognitive ...	21 Years -	Virginia Commonwealth University

Spots Global Cancer Trial Database for neurocognitive impairment