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

On day one, participants will be randomized to receive the transcranial Direct Current Stimulation (tDCS) intervention. On day two, participants receive sham intervention.

On both days 1 and 2, within two hours of completing the intervention, participants will complete cognitive assessment.

In the second phase of the trial, participants will be evaluated over 5 weeks using a mobile tDCS device and Brain Games Stimulation twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. Cognitive assessment will be conducted pre- and post-intervention using remote assessment.

On day one, participants will be randomized to receive sham intervention. On day two, participants receive the transcranial Direct Current Stimulation (tDCS) intervention.

On both days 1 and 2, within two hours of completing the intervention, participants will complete cognitive assessment.

The second phase of the trial will be conducted the same as for participants in the tDCS on Day 1 arm. Participants will be evaluated over 5 weeks using a mobile tDCS device and Brain Games Stimulation twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. Cognitive testing will be conducted pre- and post-intervention using remote assessment.

transcranial Direct Current Stimulation (tDCS) involves modulation of cerebral cortex excitability by the application of weak direct current to the scalp. tDCS is a technique that applies safe, low level direct current through large pads on the scalp to stimulate the underlying brain region, with current level \< 0.10 C/cm2. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.

transcranial Direct Current Stimulation (tDCS)

The sham intervention will be used in both arms with one arm receiving the sham intervention on day 1 and the other receiving the sham intervention on day 2. The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramp up and no intervention is provided. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.

Sham

Three tests will be used to evaluate cognitive function: Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and List Sorting Working Memory Test. These measures have a computerized format and are nationally standardized.

The Gray Oral Reading Test measures reading comprehension. Participants are asked to read a set of passages and recall specific details from the stories.

The Woodcock Johnson Understanding Directions measures listening comprehension. Participants listen to a series of complex instructions, then follow the directions by pointing to various objects in a colored picture.

Cognitive Assessment

Cognitive exercises using the Lumosity Brain Games program will be used simultaneously with the tDCS intervention. Participants will be asked to engage in training for 20 minutes a day, two days per week over 5 weeks. This program involves cognitive exercises designed to enhance executive function and processing speed.

Brain Games Stimulation

Kevin Krull, PhD

A common and potentially debilitating late effect of childhood cancer treatment is neurocognitive impairment, frequently in the domain of executive dysfunction, which can limit educational attainment, employment, and quality of life. Among the survivors of childhood acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of executive function impairment has been shown as high as 58.8%, with moderate to severe impairment as high as 33.5%, and risk for impairment increased with time from diagnosis. Given the potential of pervasive impact of neurocognitive impairment on daily life, interventions directed at reducing neurocognitive dysfunction among childhood cancer survivors with long-term follow-up are needed. This study examines the potential feasibility and efficacy of a novel intervention to improve executive function.

Primary Objectives:

* To evaluate the feasibility of a home-based intervention using Transcranial Direct Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).

Secondary Objectives:

* To estimate the efficacy of a tDCS intervention paired with cognitive training.
* To explore the short-term effect of tDCS on measures of executive function among adult survivors of childhood ALL participating in the SJLIFE protocol

tDCS is a form of non-invasive brain stimulation and is a potentially useful tool to enhance cognitive function. This study uses an at-home intervention of tDCS and cognitive training and examines its potential usefulness at improving executive function in ALL survivors.

Investigators will use tDCS to apply a low electrical current to the participant's scalp in the area of the brain associated with fluent and flexible thinking. The current may make that area of the brain work better for a short period of time. During this time, the participant will play computer games designed to train the brain to work more fluently flexibly. Researchers at St. Jude Children's Research Hospital want to see if pairing the electrical stimulation with the brain games at home is a feasible method to improve cognitive abilities in long-term survivors of childhood ALL.

In the first part of this study, the short-term effect of tDCS intervention will be evaluated in the clinical setting using a randomized cross-over trial. The survivors will be randomized to receive either the tDCS intervention or Sham on day 1, with the other treatment given on day 2. Neurocognitive testing will be conducted within two hours of completing stimulation each day.

In the second part of this study, the feasibility and potential efficacy of self-administration of the tDCS intervention paired with cognitive training will be evaluated over 5 weeks. Research participants will be taught to use the mobile tDCS device and will be provided one to take home. The device will be programmed by the investigators in advance to control the intensity and duration of the stimulation. The research participants will use the device twice per week as directed. Within two hours of completing each tDCS session participants will complete 20 minutes of cognitive training using a mobile app installed on an iPad. Neurocognitive testing will be conducted pre- and post- intervention.

Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia

Feasibility and Efficacy of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia

This outcome measures the feasibility of remote tDCS and cognitive training. The trial will be considered feasible if at least 50% of the survivors are able to complete 5 sessions (tDCS along with cognitive stimulation) successfully out of 10.

Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better.

The CCSS-NCQ is a 25 item self-report questionnaire to assess cognitive function across multiple domains in cancer survivors. Participant responses range from 1-3 for each item with higher score indicating more problems. Domain scores are created by summing the relevant item scores for each domain. Score ranges:

* NCQ Task Efficiency: 9-27.
* NCQ Emotional Regulation: 3-9.
* NCQ Organization: 3-9.
* NCQ Memory: 4-12.

The Card Sort Task measures cognitive flexibility and attention. Pictures are presented varying along two dimensions (e.g., shape and color). Participants must sort the pictures based on a given dimension. Scores range from 0-40 with higher scores indicating better function.

The Flanker Task measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Scores range from 0-40 with higher scores indicating better function.

The Working Memory Task measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Scores range from 0-28 with higher scores indicating better working memory.

Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better.

Verbal Fluency: minimum 0 with no maximum; Count of how many words were generated in 60 seconds per letter with three letters used with no top limit. Higher scores are better.

Oral Trail Making Part A: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.

Oral Trail Making Part B: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.

St. Jude Children's Research Hospital

PRISE assesses presence of side effects for several biological systems. For each organ/function system, the participant indicates the presence of a side effect, and if present, the tolerability of the side effect (tolerable or distressing). FISER and GRSEB assess side effect impact: frequency, intensity, and burden. Each domain is rated on a 7- point Likert scale.

On Campus Sham tDCS

On Campus tDCS

Participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad.

At Home tDCS

During campus visit, following randomized design each participant completed tDCS set to sham, tDCS equipment set to active condition, during two consecutive days. Participants who completed the campus visit session and evaluation then were to complete a single arm treatment of 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad.

Overall Study

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Thirty one participants completed both the tDCS equipment set to sham condition and the tDCS equipment set to active condition. Two of the 33 participants who began the overall study did not complete the second day of the campus visit. Of the 31 who completed both days of the campus visit, 28 completed the at home portion.

All participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad.

At Home Feasibility of tDCS Intervention

Participant enrollment for At Home Feasibility of tDCS intervention n=28 Participants Analyzed (Week 5 reported n=25)

Feasibility of At Home tDCS Intervention

At Home tDCS - Baseline

At Home tDCS - Follow-Up

Digit Span Forward

Task Efficiency

Memory

Organization

Emotional Regulation

Participants completed NCQ questionnaire examiner read

Neurocognitive Questionnaire: CCSS-NCQ

NIH Toolbox Card Sort Task

NIH Toolbox Flanker Task

NIH Toolbox Working Memory Function

Digit Span Backward

Verbal Fluency

Oral Trail Making Part A

Oral Trail Making Part B

Participants completed tDCS set to sham, tDCS equipment set to active condition, then were to complete 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad.

Heart and Blood Diseases

Hypertension

Prehypertension

Vascular Diseases

Participants randomly assigned to this group will be instructed to measure their blood pressure (BP) every day during the 3-month study period. BP reading will be taken using an iHealth Wireless Blood Pressure Monitor.

Participants randomly assigned to this group will be instructed to measure their BP for seven consecutive days once each month during the 3-month study period. BP reading will be taken using an iHealth Wireless Blood Pressure Monitor.

Participants will be provided with an iHealth Wireless Blood Pressure (BP) Monitor and instructions for proper use (based on a standard protocol). The iHealth device pairs easily with a cell phone or other mobile device equipped with the iHealth app (freely available on app stores for both Apple and Android devices). Participants place the cuff on their arm and press start on their mobile device. The device measures BP using the oscillometric method and automatically downloads measurements and timing to a cloud-based server.

Participants will be educated that individual BP readings can be highly variable and that any one high or low reading has little or no significance. They will also be encouraged not to measure their blood pressure more than twice in the morning and twice in the evening.

iHealth Wireless Blood Pressure Monitor

Todd M. Gibson, PhD

Second malignant neoplasms and cardiac late effects are primary drivers of serious non-recurrence morbidity and mortality in long term childhood cancer survivors. Cardiac late effects have been most prominently associated with exposure to high doses of anthracyclines or chest radiation. While increased recognition of late effects has resulted in risk-targeted therapy and reductions in use of high dose radiation and anthracyclines for many patients, these cardiotoxic exposures continue to be essential components of curative childhood cancer therapy. In addition, as survivors age they are increasingly susceptible to other general risk factors for cardiovascular disease recognized in the general population, such as hypertension, obesity, dyslipidemia, and diabetes.

This study will evaluate a high blood pressure monitor (HBPM)-based intervention for the early detection of pre-hypertension and prevention of clinical hypertension in survivors of childhood cancer. Eligible and consenting participants will be randomized into one of three groups:

GROUP 1: Instructed to measure blood pressure (BP) every day for 3 months. GROUP 2: Instructed to measure BP for 7 consecutive days once a month, for 3 months.

GROUP 3: Instructed to measure blood pressure for 3 consecutive days each month, for 3 months.

The randomization to the above groups will be done using sequential assignment of newly recruited participants based on a randomly ordered list.

PRIMARY OBJECTIVE:

* Evaluate the feasibility of High Blood Pressure Monitoring (HBPM) for three consecutive months using a remote blood pressure device provided to participants of the St. Jude Lifetime cohort (SJLIFE) protocol.

SECONDARY OBJECTIVES:

* Assess compliance with use of HBPM by measurement frequency, evaluating overall and defined minimum use in each of the three different groups.
* Assess compliance with use of HBPM by cell phone status, evaluating those with and without a personal cell phone capable of connecting directly to the home blood pressure monitoring device via Wi-Fi or Bluetooth network.

The proposed research and testing being done during this study includes:

1. Screening evaluation and consent - Individuals will be asked questions to help the investigators determine if they are eligible to participate. This includes questions about medical history pertaining to blood pressure, medicines, and certain medical conditions, and if the individuals are willing to use the technology provided by the study. For individuals who are eligible to participate, an opportunity will be provided to discuss the study and complete the consent process.
2. Group assignment and randomization - Participants will be randomly assigned to one of three groups: a study team member will select one of sixty identical envelopes, each containing a group assignment, with 20 envelopes containing each of the three group assignments. This random group assignment determines the frequency with which participants will monitor their blood pressure at home. The randomization between three different groups will help investigators determine how often survivors can consistently monitor their blood pressure.
3. Educational session - After participants have been assigned to a group, they will be instructed on how to set up and use the home blood pressure monitoring device.
4. Monitoring blood pressure at home - Participants will be asked to monitor their blood pressure at home in the morning and evening using a remote monitoring device over a three-month period. Frequency of monitoring depends on the random group assignment. The device is the iHealth Wireless Blood Pressure Monitor which is a wireless blood pressure monitoring device that fits snugly around one arm and automatically measures and records blood pressure in about one minute. The device will be paired with the participant's smart phone or study-provided iPod Touch, which is then used to operate the device and save the blood pressure readings. After completion of the three-month monitoring period, participants will be asked to return the device (and iPod Touch, if applicable).
5. Reminders to use the device - Participants are to start monitoring their blood pressure when they return home after completion of their St. Jude visit. During the educational session, participants will be asked to set up reminders on their smart phone or study-provided iPod Touch to alert them to monitor their blood pressure. Depending on how often they are assigned to monitor their blood pressure, they may also receive email and/or text reminders to prompt them to monitor their blood pressure. In addition, a study team member may contact them if they have three or more measurements above 140/90 mm Hg, as that reading is considered hypertensive. A study team member may contact participants if they are not monitoring as specified by their group assignment to attempt to troubleshoot any barriers and/or technical issues.

Assessing Blood Pressure Remotely in Childhood Cancer Survivors

Feasibility of Assessing Blood Pressure Remotely in Childhood Cancer Survivors (Pilot Study-Survivor)

The proportion of participants who meet or exceed the defined minimum level of compliance with recording of scheduled blood pressure measurements will be reported. Minimum use is defined as:

Groups 1 and 2: Successful recording of 12 measurements (maximum 2 per day, one morning and one evening) over any 7 day period in at least 2 of the 3 months of the study.

Group 3: Successful recording of two measurements each day (morning and evening) for three consecutive days, at least once in each of the 3 months of the study.

The overall compliance rate for each group will be calculated as the number of measurements recorded divided by the number of measurements scheduled.

Calculations will be done for participants who own a smart phone compatible with the HBPM device compared to those who need to be supplied with an additional device to pair with the HBPM device. The overall compliance for each group will be calculated as the number of measurements recorded divided by the number of measurements scheduled.

Worksites in this arm will receive the standard HealthLinks intervention protocol, which includes on-site consulting, toolkits, and support via telephone and email to implement a worksite wellness program and adopt evidence-based practices.

Worksites in this arm will receive the standard HealthLinks intervention protocol, which includes on-site consulting, toolkits, and support via telephone and email plus support to form a worker wellness committee to implement a worksite wellness program and adopt evidence-based practices.

Worksites in this arm will not receive an intervention during the study. After they have provided their final follow-up data, they will receive the HealthLinks intervention.

HealthLinks

Margaret A Hannon, PhD, MPH

The proposed project will answer key questions about implementing evidence-based health promotion interventions at small and low-wage worksites. Small, low-wage worksites will be randomized to receive HealthLinks (a free American Cancer Society program to disseminate evidence-based interventions), HealthLinks+ (which will include creating worksite wellness committees as part of the program), or to serve in a delayed control group. This approach will identify successful strategies for implementing evidence-based interventions at low-wage worksites to improve workers' cancer screening, healthy eating, physical activity, and tobacco cessation.

Cancer and other chronic diseases are leading killers and disablers in the United States, and low-income Americans are at high risk for these diseases. Multiple evidence-based interventions (EBIs) exist to improve chronic disease risk behaviors, such as cancer screening, healthy eating, physical activity, and tobacco cessation, yet EBI reach to community settings is poor. Among community settings for reaching low-income adults, worksites stand out because most low-income adults are employed, but worksite implementation of health-promoting EBIs is low. Half of American workers work in small or low-wage worksites, where implementation of these EBIs and readiness to implement are especially low. Even though decision-makers at these worksites are often motivated to promote worker health, they usually have no dedicated wellness staff and face three major barriers in implementing EBIs: 1) lack of awareness of the potential benefits of EBIs, 2) lack of knowledge to choose EBIs, and 3) lack of financial and personnel resources to implement EBIs. Non-profit organizations and others who would assist these worksites face their own barriers. Organizational readiness to implement EBIs is not well understood, and few validated measures are available, especially for worksites. Without reliable and valid measures of worksite readiness, those who would assist them have difficulty: a) identifying worksites that are ready, and b) helping decision-makers get ready to increase their odds of implementation success. The proposed research will address both sets of barriers and contribute to dissemination and implementation research by testing the efficacy of a worksite EBI dissemination program, HealthLinks, developed in partnership with the American Cancer Society, a non-profit organization operating nationwide. HealthLinks is based on Greenhalgh's diffusion of innovations framework and Rogers' diffusion of innovations theory and addresses small and low-wage worksites' barriers by providing free on-site information and recommendations for EBIs and by providing free on-site programs and temporary staffing to assist implementation. We will test HealthLinks via a 3-arm randomized controlled trial. Worksites will receive either 1) HealthLinks, or 2) an enhanced version of HealthLinks that addresses small worksites' lack of personnel by adding worker wellness committees, or will 3) serve in a delayed control group that receives HealthLinks at study end. We will measure worksites' EBI implementation at baseline, 12 months (at the end of the intervention period), and 24 months (to assess maintenance one year after the intervention ends). This design will test the effectiveness of both HealthLinks and of worker wellness committees. We will also measure the effect of both on workers' health behaviors at baseline, 12 months, and 24 months. Finally, we will develop, pilot-test, and validate a measure of worksite readiness to implement EBIs.

Increasing Implementation of Evidence-based Interventions at Low-wage Worksites

The intervention being tested promotes a package of evidence-based health promotion interventions. The primary outcome is the proportion of these interventions the worksites are implementing at each time-point assessed.

Workers at participating worksites will complete brief surveys at each time-point assessed that measure their health behaviors related to breast, cervical, and colon cancer screening, healthy eating, physical activity, and tobacco use/cessation.

National Cancer Institute (NCI)

University of Washington

Associate Professor

All Drugs and Chemicals

Nicotine

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Participants will receive NRT and Motivational Interviewing counseling

Motivational Interviewing; 8 weeks of counseling

Varenicline plus Motivational Interviewing counseling

Brief advice, one time during initial session

Varenicline without counseling

Kolawole S Okuyemi, MD,MPH

the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.

Despite significant declines in cigarette smoking rates among adults in the United States in the last few decades, smoking rates remain high among poor and underserved populations. One underserved group is the 4 million homeless persons in the US among whom cigarette smoking rate is an alarming 70% or more; these rates are 3 times higher than national average. Two of the three leading causes of death among homeless persons, heart disease and cancer are tobacco related.2, 3 Despite very high smoking prevalence and disease burden in this population smoking cessation research have not been extended to the homeless. Recent studies including data from our research team show a considerable degree of readiness to quit smoking by homeless smokers and that nicotine replacement therapy (NRT) plus counseling show promise. However, homeless persons face many challenges that may constitute barriers for them to adhere to smoking cessation treatments even if such treatments have been proven effective in the general population. In order to reduce smoking-related health disparities within this underserved population, it is critical that cessation interventions including strategies to improve treatment adherence be developed to include homeless smokers. The primary aim of this study is to assess the effects of adherence-focused motivational interviewing (MI) to help homeless persons quit smoking.

Recruitment and retention will be enhanced by use of bus passes for transportation, debit cards, attractive intervention materials, collaboration with homeless shelters, and advice from a community advisory board. If successful, this study will provide a model for how to overcome barriers to cancer prevention services among homeless persons. It will also provide the impetus for policy changes directed at increasing homeless persons' access to smoking cessation pharmacotherapy and treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia	NCT02336282	Acute Lymphobla...	transcranial Di... Sham Cognitive Asses... Brain Games Sti...	18 Years -	St. Jude Children's Research Hospital
Assessing Blood Pressure Remotely in Childhood Cancer Survivors	NCT02476162	Hypertension	iHealth Wireles...	18 Years -	St. Jude Children's Research Hospital
Increasing Implementation of Evidence-based Interventions at Low-wage Worksites	NCT02005497	Cancer Health Promotio...	HealthLinks	21 Years -	University of Washington
Improving Varenicline Adherence and Outcomes in Homeless Smokers	NCT00786149	Tobacco Use Ces...	Varenicline plu... Varenicline wit...	18 Years -	University of Minnesota
Improving Varenicline Adherence and Outcomes in Homeless Smokers	NCT00786149	Tobacco Use Ces...	Varenicline plu... Varenicline wit...	18 Years -	University of Minnesota

Spots Global Cancer Trial Database for cancer prevention and control