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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-02265 | Registry Identifier | NCI Clinical Trial Registration Program |
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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:
SECONDARY OBJECTIVES:
The proposed research and testing being done during this study includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Daily for 3 Months | 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. |
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| Group 2: Daily for 1 Week/Month | 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. |
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| Group 3: 3 Consecutive Days Once/Month | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iHealth Wireless Blood Pressure Monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who meet or exceed defined minimum use of HBPM device by group | 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. | From Day 0 through 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance rate for the use of the HBPM device by group measurement frequency | The overall compliance rate for each group will be calculated as the number of measurements recorded divided by the number of measurements scheduled. | From Day 0 through 3 months |
| Proportion of participants who comply with the use of HBPM device by cell phone status |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Todd M. Gibson, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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. |
| From Day 0 through 3 months |
| Number of participants who fail to record any blood pressure measurements over the course of a month | From Day 0 through 3 months |
| Proportion of participants by group who recorded at least 80% of scheduled measurements | From Day 0 through 3 months |