Clinical trial · Interventional
Hypertension Management in Cancer Patients
Hypertension Management in Cancer Patients: Bringing PCPs "Back" Into Cancer Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Initially suspended due to Covid-19. After much consideration, it was determined that we do not have the bandwidth to resume recruitment or any activities for this project.
Summary
Brief summary (as posted)
The investigators propose to leverage new technology using the Qardio app for iPhone and Android devices to automatically upload blood pressures, using a well-validated blue tooth blood pressure monitor (QardioArm), directly into the Duke electronic health record system (EPIC). Further, the investigators propose to develop an automated EHR (electronic health record) messaging system utilizing the home blood pressures that will be sent to the participant's PCP, with copies to the participant and the primary oncologist. This is a 12-week prospective non-randomized implementation study. 40 patients who are 18-74 years old who fall under the following criteria will be screened: 10 women with Stage 1-III breast cancer who are receiving either an anthracycleine of antiHER2 therapy, 10 men with prostate cancer on ADT, 10 individuals with CLL on ibrutinib therapy, and 10 individuals who are hematopoietic stem cell transplantation (HSCT) survivors. In Phase 1 (Weeks 1-4) of the study, participants will self-monitor their blood pressure using the QardioArm wireless upper arm blood pressure monitor 3 times per week. In Phase 2 (Weeks 5-12), the investigators will implement the auto-messaging system triggered by an abnormal weekly average systolic or diastolic blood pressure. The investigators will adapt the conceptual framework of Muldoon and colleagues whereby home blood pressure monitoring is combined with office blood pressures to optimize data for the primary care provider's clinical decision making. {Participants will be asked to complete a paper survey, upon enrollment, that will include life chaos and medication adherence questions. There will also be an end-of-study feedback survey (usability and acceptability questions through REDCap) for both the participants and their primary care providers. This is an implementation study with a descriptive analysis. The data generated from the study will be used in future studies, including testing of different interventions aimed at optimizing blood pressure control among patients on active cancer therapy. This study presents no greater than minimal risk to the subjects and adverse events are not anticipated.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Pressure | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Hematopoietic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hypertension | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated Messaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- QardioArm and Messaging System
- description
- Participants will self-monitor their blood pressure using the Qardio Bluetooth device and obtain 3 separate blood pressure measurements per week (2 morning, 1 evening) for 12 weeks. An automated messaging system for blood pressure management will be triggered by a weekly average systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg. This automated message will be sent to the participant's primary care provider, with copies to the participant and the primary medical oncologist.
- interventionNames
- Other: Automated Messaging
Primary outcomes (5)
- measure
- Patient Adherence
- timeFrame
- 12 weeks
- description
- To determine the proportions of patients who completed the 3 blood pressure measurements per week (goal of 80% adherence).
- measure
- Patient Blood Pressure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * A total of 40 patients with a diagnosis of hypertension who are 18-74 years old who fall under the following criteria will be screened: * 10 women with Stage I-III breast cancer who are on active cancer therapy and are receiving either an anthracycline (doxorubicin) or antiHER2 (trastuzumab or pertuzumab) * 10 men with prostate cancer on androgen deprivation therapy (ADT) * 10 individuals with CLL on ibrutinib therapy * 10 HSCT survivors (who had a malignancy) * Have a smartphone (iPhone or Android) * Have a Duke primary care provider and Duke oncologist (who is being treated at the Duke Cancer Center) * Have access or willing to set up access to Duke MyChart. * English speaking patients
References
Publications (0)
Data not yet available