Hypertension Management in Cancer Patients

NCT03919214 | Terminated

• 1 other identifier: Pro00102260
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Blood Pressure; Hypertension; Cancer; Cancer, Breast; Cancer of Prostate; CLL; Hematopoietic Malignancy

Outcome Measures

Primary Outcomes (5)

• Patient Adherence

  To determine the proportions of patients who completed the 3 blood pressure measurements per week (goal of 80% adherence).

  12 weeks

• Patient Blood Pressure

  To determine the proportions of patients, by disease group, who have a blood pressure that is above (or below) the target levels.

  12 weeks

• Primary Care Provider Activation

  To determine the proportions of primary care providers who (a) received and (b) acted upon the automated message.

  12 weeks

• End of Study Patient Blood Pressure - Within Target Levels

  To determine the proportions of patients who are within target levels with the final weekly average pressures.

  1 week (end of study)

• End of Study Patient Blood Pressure - Outside of Target Levels

  To determine the proportions of patients who are outside of target levels with the final weekly average pressures.

  1 week (end of study)

Secondary Outcomes (3)

• Clinic-based Blood Pressure

  12 weeks

• Usability of QardioArm device

  1 week (end of study)

• Acceptability of the Messaging System

  1 week (end of study)

Study Arms (1)

QardioArm and Messaging System

OTHER

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.

Other: Automated Messaging

Interventions

Automated Messaging OTHER

This is a 12-week prospective study with two phases. Participants will use the QardioArm device to obtain 3 separate blood pressure measurements per week (2 morning, 1 evening). The QardioArm device will only be used as a tool to gather data. In Phase 1 (Weeks 1-4), participants will self-monitor their blood pressure using the Qardio Bluetooth device. In Phase 2 (Weeks 5-12), we will implement the auto-messaging system triggered by a weekly average systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg.

Also known as: QardioArm Blood Pressure Measurements and Automated Messaging

QardioArm and Messaging System

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)
• men with prostate cancer on androgen deprivation therapy (ADT)
• individuals with CLL on ibrutinib therapy
• 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

Sponsors & Collaborators

• Duke University: lead
• Duke Institute for Health Innovation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypertension; Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 18, 2019
• Study Start: December 10, 2019
• Primary Completion: June 3, 2020
• Study Completion: June 3, 2020
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)