This phase II trial studies how well intensive blood pressure management works in decreasing systolic blood pressure in patients with kidney or thyroid cancer that has spread to other places in the body (metastatic) who are starting anti-angiogenic tyrosine kinase inhibitor cancer therapy. This study is being done to find out if a systolic blood pressure to a target of less than 120 mmHg (intensive systolic blood pressure management) can be achieved, well tolerated, and beneficial as compared to the usual approach to a target of less than 140 mmHg while taking an anti-angiogenic tyrosine kinase inhibitor. This study may help doctors understand the best way to control blood pressure in kidney or thyroid cancer patients taking anti-angiogenic tyrosine kinase inhibitor.
PRIMARY OBJECTIVE: I. To determine the feasibility of an intensive (systolic blood pressure \[SBP\] \< 120 mmHg) "Intervention" versus standard care (SBP \< 140 mmHg) "Non-Intervention" approach to blood pressure (BP) control in metastatic renal cell and thyroid cancer patients initiating anti-angiogenic tyrosine kinase inhibitors. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive intensive systolic blood pressure management for 6 months. Patients receive increased blood pressure medication every 2 weeks while systolic blood pressure is 120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1 day) every 2 weeks and upload the recorded blood pressure readings to the provider and to a central blood pressure monitoring team. Patients with changes in blood pressure medications monitor blood pressure readings on 3 days in 1 week (4 times in 1 day). ARM B: Patients receive standard blood pressure management for 6 months. Patients receive blood pressure medications per doctor's instruction. Patients also monitor blood pressure at home 1 day (4 times in 1 day) every 2 weeks and upload the recorded blood pressures to a central monitoring team.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Receive usual blood pressure management
Undergo blood pressure measurement
Undergo intensive systolic BP management
Ancillary studies
Ancillary studies
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, United States
...and 15 more locations
Differences in systolic blood pressure (SBP) based on automated office BP measurements
Differences in SBP over the 6- month study period between intensive BP control (intervention) versus standard care (non-intervention group) will be compared using the "difference-indifference" method. All mixed effects models will be estimated using generalized estimating equations (GEE).
Time frame: Up to 6 months
Difference in SBP based on all automated home and office BP measurements
Based on all automated home and office BP measurements.
Time frame: Up to 6 months
Study retention rates
Will compare the study retention rates between the intensive SBP versus standard care group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation
Time frame: Up to 6 months
Frequency of automated home SBP measurements > 180 mmHg or < 90 mmHg or diastolic (D)BP > 110 mmHg
The frequency of orthostatic hypotension as defined by \> 20 mmHg decreases in office SBP with standing; or symptomatic hypotension, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) criteria, in participants in the intervention and non-intervention group arms.
Time frame: Up to 6 months
Differences in symptoms and health-related quality of life
Will compare the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue between the intensive SBP versus standardlcCare group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation.
Time frame: Up to 6 months
Differences in patient-reported medication compliance
Will compare the medication compliance between the intensive SBP versus standard care group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation.
Time frame: Up to 6 months
Patient-rated adverse events associated with hypertension, hypotension and anti-hypertensive medications
Time frame: Up to 6 months
Participant satisfaction with BP care
The participant satisfaction with BP care (including the C-BAC and the related technologies) and BP medications will be evaluated through questionnaires evaluated on a Likert scale and via open ended discussions with focus groups.
Time frame: Up to 6 months
Provider satisfaction with BP care
The provider satisfaction with BP care (including the C-BAC and the related technologies) and BP medications will be evaluated through questionnaires evaluated on a Likert scale and via open ended discussions with focus groups.
Time frame: Up to 6 months
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