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NCT02476162 · ClinicalTrials.gov registry record
Assessing Blood Pressure Remotely in Childhood Cancer Survivors
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 60
- Enrollment target
NCT02476162 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 60 participants.
The verdict
NCT02476162 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
Study Summary
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 direc
Interventions
- DEVICE iHealth Wireless Blood Pressure Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02476162
The ClinicalTrials.gov registry entry for NCT02476162 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which iHealth Wireless Blood Pressure Monitor is the first listed.
NCT02476162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02476162 about?
NCT02476162 is a clinical study titled "Assessing Blood Pressure Remotely in Childhood Cancer Survivors". 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 increa...
What is the current status of trial NCT02476162?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2015-06. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02476162?
The interventions under investigation include: iHealth Wireless Blood Pressure Monitor (DEVICE).
Who is sponsoring clinical trial NCT02476162?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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