Clinical trial NCT02476162: Assessing Blood Pressure Remotely in Childhood Cancer Survivors
Official title: Feasibility of Assessing Blood Pressure Remotely in Childhood Cancer Survivors (Pilot Study-Survivor)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Childhood Cancer Survivor
Cancer Prevention and Control
Blood Pressure Monitoring
Pre-Hypertension
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients at St. Jude Children's Research Hospital who are currently enrolled on the SJLIFE protocol, and who meet all eligibility requirements.

Brief 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 directly to the home blood pressure monitoring device via Wi-Fi or Bluetooth network.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Enrollment on the St. Jude protocol: SJLIFE
* Arm circumference between 22-47 cm
* Willing to use and return the technology provided by the study

Exclusion Criteria:

* Medical history of atrial fibrillation or arrhythmia
* Currently taking anti-hypertensive medications

Primary outcomes:
measure: Proportion of participants who meet or exceed defined minimum use of HBPM device by group
timeFrame: From Day 0 through 3 months
Secondary outcomes:
measure: Compliance rate for the use of the HBPM device by group measurement frequency
timeFrame: From Day 0 through 3 months
measure: Proportion of participants who comply with the use of HBPM device by cell phone status
timeFrame: From Day 0 through 3 months
measure: Number of participants who fail to record any blood pressure measurements over the course of a month
timeFrame: From Day 0 through 3 months
measure: Proportion of participants by group who recorded at least 80% of scheduled measurements
timeFrame: From Day 0 through 3 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Todd M. Gibson, PhD
role: PRINCIPAL_INVESTIGATOR
References: