NCT03919214

Hypertension Management in Cancer Patients

Terminated NA Last updated 19 April 2023

What this trial tests

NA trial testing Automated Messaging in Blood Pressure in 4 participants. Terminated before completion.

Timeline

10 December 2019

Primary endpoint
3 June 2020

3 June 2020

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	4
Start date	10 December 2019
Primary completion	3 June 2020
Estimated completion	3 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Automated Messaging

Conditions studied

• Blood Pressure — all drugs for Blood Pressure →
• Hypertension — all drugs for Hypertension →
• Cancer — all drugs for Cancer →
• Cancer, Breast — all drugs for Cancer, Breast →

Sponsor

Duke University

Who can join

Adults 18 to 74, any sex, with Blood Pressure or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardiometabolic Comorbidities in Cancer Survivors: <i>JACC: CardioOncology</i> State-of-the-Art Review.
   Zullig LL, Sung AD, Khouri MG, Jazowski S, et al · · 2022 · cited 61× · PMID 35818559 · DOI 10.1016/j.jaccao.2022.03.005
2. Risks and management of hypertension in cancer patients undergoing targeted therapy: a review.
   Zhu X, Wu S. · · 2022 · cited 10× · PMID 35568958 · DOI 10.1186/s40885-022-00197-3