Heart and Blood Diseases

All Conditions

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.

St. Jude Children's Research Hospital

Behaviors and Mental Disorders

Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Anxiety Disorders

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Standard home blood pressure measurement at home

Participant listens to a pre-recorded hypnosis script (approx 5 mins long) prior to standard home blood pressure measurement.

Measurement of Blood Pressure using Home blood pressure monitor

Group 1. Standard Home Blood Pressure Measurement

Pre-recorded clinical hypnosis script (approx 5 mins long) used prior to standard home blood pressure measurement. Clinical Hypnosis is used as a non-pharmacological technique for reducing procedural anxiety, distress and discomfort with patients.

Group 2. Hypnosis script prior to home blood pressure measurement

Gabriel Dabscheck, MBBS FRACP

This study has two primary objectives. The first is to determine if it is feasible and reliable for children and families with a diagnosis of Neurofibromatosis Type 1 (NF1) to use of blood pressure (BP) monitor at home.

The second is to determine if there is a difference between a child's measured home BP using standard instructions or using a clinical hypnosis script. This will be determined by a randomised control trial design.

Standard and hypnosis Home BP will be compared to the gold standard measurement of BP measured by a trained health care professional in clinic.

Children who participate will complete a clinic-based BP with a health care professional, then will be randomised into either the standard home BP measurement or using a hypnosis script prior to BP measurement.

Neurofibromatosis Type 1 (NF1) is a rare autosomal dominate genetic disorder that affects an estimated that 1 in 2500 people or 10000 Australians. NF1 affects multiple systems throughout the body. The prevalence of hypertension(HTN) in children and adolescents in the general population is approximately 3.5%. Children and adolescents with a diagnosis of NF1 have an increased incidence of HTN, and has been documented as high as 6.1% to 12%. This is two times higher than the general population.

Clinical adherence to the recommendation of recording annual blood pressure on patients has not been audited. The anecdotal experience of the authors is that most children do not have annual blood pressure (BP) measurements. With the increased uptake of telehealth following the COVID-19 pandemic, children and families may not be reviewed in person for significant periods of time as they prefer consultations over telehealth. As a result, children may miss having their annual blood pressure measured. As a young people with a diagnosis of NF1 have twice the risk of HTN, annual BP measurement is essential.

The American Academy Paediatrics guideline outlines the best practice for BP measurement to ensure true BP reading: The child should be seated in a quiet room for 3-5 minutes before measurement, with back supported and feet uncrossed on the floor. The blood pressure should be measured on the right arm, using the correct sized cuff. This should be completed by a trained clinician. As part of this study, all participants will have a manual sphygmomanometer in clinic-based BP taken on day of recruitment.

One of the primary objectives of this study is to determine if is feasible to use home blood pressure monitoring to screen children with NF1 for hypertension.

Clinical Hypnosis is used as a non-pharmacological technique for reducing procedural anxiety, distress and discomfort with patients. Hypnosis scripts have been successfully used as non-pharmacological adjuncts to reduce pain and anxiety in adult patients undergoing interventional radiological procedures, demonstrating that the benefits of hypnosis techniques can be accessible to patients with little or no training or preparation. Furthermore, healthcare workers who are not experts in hypnosis can be trained to deliver scripts effectively.

If a hypnosis script used while taking home blood pressure readings allows for a calm child and an equivalent clinic BP measure, hypnosis script and home BP monitoring could have greater application across the Royal Children's Hospital.

Therefore the second aim of the study is to see if there is a difference in a child's BP measurements comparing a standard home BP measurement or utilising a calming hypnosis script prior to home BP measurement. This will be compared to the gold standard clinic-based BP measurement completed by a trained professional. The child's self-reported level of anxiety using the Children's Anxiety Meter Scale (CAM-S) will be measured after every BP measurement. In addition, family's perceptions of the process of home BP monitoring will also be collected.

Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1

Feasibility and Comparison Study of Home Blood Pressure Monitoring and Clinical Hypnosis in Children With Neurofibromatosis Type 1

The de-identified data set collected for this study will be available six months after publication of the primary outcome.

The study protocol, analysis plan and consent forms will also be available. The data may obtained from the Murdoch children's Research institute by emailing gabriel.dabscheck@rch.org.au Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the trial steering committee must see and approve the analysis plane describing how the data will be analysed, there must be and agreement around appropriate acknowledgement and and additional costs involve must be covered. Should the trial steering committee be unavailable, this role is delegated to the Murdoch children's Research Institute. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.

Three measures of Systolic/diastolic reading (mmHg) using manual sphygmomanometer by trained professional. Following The American Academy Pediatrics guidelines for best practice for blood pressure (BP) measurement to ensure true BP reading.

One reading of systolic/diastolic reading (mmHg) using automatic oscillometer BP monitor by trained professional - Following The American Academy Pediatrics guidelines for best practice for blood pressure (BP) measurement to ensure true BP reading.

Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.

Measurement of participant's reported state of anxiety in clinic when completing BP measurement using Children's Anxiety Meter Scale (CAM-S).

CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale.

0 = calm, not nervous or worried 10 = very very nervous and worried

Daily measure of the participants reported state of anxiety when completing BP measurement at home using Children's Anxiety Meter Scale (CAM-S).

CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale.

0 = calm, not nervous or worried 10 = very very nervous and worried

Study specific survey. Likert scales used to assess parent/caregiver perception with ease of use of home BP monitor, timeliness to complete measures and interference with family life compared to attending hospital appointment, ease of receiving and returning equipment, and financial cost to attend hospital appointment.

Data will be reported for each item individually, as the proportion of parents/caregivers who responded positively on the Likert scale, where higher scores indicate less favorable responses.

Murdoch Childrens Research Institute

Blood and Lymph Conditions

Immune System Diseases

Substance Related Disorders

Wounds and Injuries

Leukemia

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Cardiotoxicity

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Acalabrutinib

Ibrutinib

Patients receiving ibrutinib for the treatment of CLL.

Patients receiving acalabrutinib for the treatment of CLL.

ECG to monitor electrical activities of the heart on each visit

Electrocardiogram

Echocardiogram

Cardiac magnetic resonance imaging

Mobile cardiac telemetry at baseline and 6 months

Mobile cardiac telemetry

Home blood pressure monitoring three times per week

Blood pressure monitoring

Blood draw

Inhye Ahn, MD

This is a multicenter, prospective, observational cohort study to comprehensively and longitudinally evaluate and characterizes the cardiovascular events with CLL patients who are initiating treatment with a Bruton's tyrosine kinase (BTK) inhibitor ibrutinib or acalabrutinib.

This research study includes three visits for research blood, physical exam, and cardiac testing at baseline, 3 months, and 6 months. The study will collect the following data during the 6-month study period:

* Blood sample collection
* Electrocardiogram (ECG)
* Echocardiogram
* Cardiac magnetic resonance imaging (MRI)
* Mobile cardiac telemetry
* Blood pressure measurement

Samples With DNA: Samples retained, with potential for extraction of DNA from at least one of the types of samples retained (e.g., frozen tissue, whole blood)

Cardiotoxicities in Patients Receiving BTKi

A Multicenter, Prospective Cohort Study for Detection of Cardiotoxicities in Patients Receiving Ibrutinib or Acalabrutinib for CLL

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Any documented evidence of atrial arrhythmia including symptomatic and asymptomatic events captured by EKG, 28-day mini cardiac telemetry, or monitoring of cardiac rhythm during echocardiogram or cardiac MRI.

NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing Blood Pressure Remotely in Childhood Cancer Survivors	NCT02476162	Hypertension	iHealth Wireles...	18 Years -	St. Jude Children's Research Hospital
Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1	NCT05196854	Hypertension Neurofibromatos... Blood Pressure	Group 1. Standa... Group 2. Hypnos...	5 Years - 18 Years	Murdoch Childrens Research Institute
Cardiotoxicities in Patients Receiving BTKi	NCT05521178	Chronic Lymphoc... Small Lymphocyt...	Electrocardiogr... Echocardiogram Cardiac magneti... Mobile cardiac ... Blood pressure ... Blood draw	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for blood pressure monitoring