Assessing Blood Pressure Remotely in Childhood Cancer Survivors

Completed

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID
NCT02476162
Run by
St. Jude Children's Research Hospital
People needed
60
Starts
2015-06-01
Expected to finish
2016-01-01
Last updated by the study team
2016-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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