RECRUITING

Telemonitoring Hypertension and Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial-prospective study will provide important information on equitable implementation strategies to improve hypertension management in women with breast cancer by evaluating the feasibility and safety of remote hypertension management using home blood pressure telemonitoring that will provide individualized hypertension management, health and wellness education for hypertension prevention of women with breast cancer stages I-IV. Also this study may provide evidence to inform a potential paradigm shift in joint social and clinical management of hypertension that future studies may use to address complex social and clinical comorbidities that affect women with hypertension in Mississippi. The main questions this study aims to answer are: 1. To examine the feasibility of using home BP telemonitoring to provide individualized hypertension management in a population of women with breast cancer and food insecurity. 2. To examine the effectiveness of telemonitoring in achieving 2017 ACC/AHA guidelines for hypertension control in women with breast cancer and food insecurity using the RE-AIM framework. 3. To pilot the integration of a community service partnership to decrease food insecurity in the 40 women who participate in the home BP telemonitoring program. Using the mailed telemonitoring kit (iPad tablet and Blood Pressure Cuff) the participants of this study will be asked to access a daily health session using iPad and obtain a blood pressure measurement using blood pressure cuff that transmits readings wirelessly via Bluetooth to the tablet which is uploaded directly to the participants UMMC electronic health records. Participants are asked to obtain two consecutive blood pressure measurements during each session and register at least 6 sessions per week. The study duration will be 6 months. Every 2 weeks blood pressure measurements will be assessed. If less than 75% of measurements are at goal systolic blood pressure 75% of measurements are at goal systolic blood pressure\<130mmHg and diastolic blood pressure \<80mmHg, the patients nurse coordinator will contact them via telephone and assess for medication adherence and report to the patient's primary care provider and oncologist.

Official Title

Tracking Social Outcomes of Hypertension in Women With Breast Cancer

Quick Facts

Study Start:2023-02-01

Study Completion:2023-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05574686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Eligibility and exclusion criteria are intended to capture a population broadly representative of breast cancer patient's stages I-IV with hypertension, while excluding patients with hypertension complicated by major co-morbidities as determined by chart review who would not be appropriate for algorithmic management. * Clinical/study eligibility will be confirmed by the patient's Breast Oncologist and/or Primary Care Providers who will refer identified patients or provide permission for outreach to eligible patients for recruitment into the pilot study. * Patients eligible for the intervention must meet all eligibility criteria intended to identify breast cancer patients with hypertension and positive screening for food insecurity according to the 2017 ACC/AHA Guidelines, healthcare provider hypertension diagnosis and Hunger Vital Signs Tool United States Departments of Agriculture: * Women ages 18 years and older UMMC breast cancer patients in stages I-IV as primary diagnosis within the last three years and who were diagnosed with hypertension exceeding 2017 ACC/AHA guidelines of ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg will be identified from UMMC electronic health records (EHR). * Women ages 18 years and older UMMC breast cancer patients in stages I-IV as a primary diagnosis within the last three years with physician-coded hypertension, who have their most recently documented blood pressures exceeding 2017 ACC/AHA guidelines of ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg in at least three consecutive instances in the EHR, three consecutive high BP measurements within 12 months, consistent with SNOMED coded phenotypes for hypertension identify from UMMC EHR records (A diagnosis of hypertension). * Positive screening for food insecurity via the Hunger Vital Signs tool, a validated two-question screening tool based on the United States Department of Agriculture. * Ability to speak English. * Reliable access to internet, video and telephone services.	* Stage 4 or 5 kidney disease (eGFR \<30 ml/min/1.73m2 on the most recent measurement) * Acute coronary syndrome, coronary revascularization, stroke, or other major cardiovascular event within the past 3 months * Known secondary causes of hypertension including coarctation of the aorta, pheochromocytoma, and adrenal cortical hypertension * Prescribed 3 or more antihypertensive medications * Class III or IV New York Heart Association heart failure or left ventricular ejection fraction \<50% * Institutionalized (i.e., nursing home) or limited life expectancy as determined by chart review including advanced stage cancer, severe frailty, or other major comorbidity * Further exclusion criteria include unwillingness to be followed for the duration of the study, participation in another clinical trial or research study, difficulty with communication in English without an interpreter over the telephone, substance abuse, dementia, disability or mental illness that would prohibit ability to provide informed consent or perform home BP monitoring. Additionally, patients are ineligible if they report a major health event requiring hospitalization since the last documented UMMC clinic visit.

Inclusion Criteria

Exclusion Criteria

* Eligibility and exclusion criteria are intended to capture a population broadly representative of breast cancer patient's stages I-IV with hypertension, while excluding patients with hypertension complicated by major co-morbidities as determined by chart review who would not be appropriate for algorithmic management.
* Clinical/study eligibility will be confirmed by the patient's Breast Oncologist and/or Primary Care Providers who will refer identified patients or provide permission for outreach to eligible patients for recruitment into the pilot study.
* Patients eligible for the intervention must meet all eligibility criteria intended to identify breast cancer patients with hypertension and positive screening for food insecurity according to the 2017 ACC/AHA Guidelines, healthcare provider hypertension diagnosis and Hunger Vital Signs Tool United States Departments of Agriculture:
* Women ages 18 years and older UMMC breast cancer patients in stages I-IV as primary diagnosis within the last three years and who were diagnosed with hypertension exceeding 2017 ACC/AHA guidelines of ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg will be identified from UMMC electronic health records (EHR).
* Women ages 18 years and older UMMC breast cancer patients in stages I-IV as a primary diagnosis within the last three years with physician-coded hypertension, who have their most recently documented blood pressures exceeding 2017 ACC/AHA guidelines of ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg in at least three consecutive instances in the EHR, three consecutive high BP measurements within 12 months, consistent with SNOMED coded phenotypes for hypertension identify from UMMC EHR records (A diagnosis of hypertension).
* Positive screening for food insecurity via the Hunger Vital Signs tool, a validated two-question screening tool based on the United States Department of Agriculture.
* Ability to speak English.
* Reliable access to internet, video and telephone services.

* Stage 4 or 5 kidney disease (eGFR \<30 ml/min/1.73m2 on the most recent measurement)
* Acute coronary syndrome, coronary revascularization, stroke, or other major cardiovascular event within the past 3 months
* Known secondary causes of hypertension including coarctation of the aorta, pheochromocytoma, and adrenal cortical hypertension
* Prescribed 3 or more antihypertensive medications
* Class III or IV New York Heart Association heart failure or left ventricular ejection fraction \<50%
* Institutionalized (i.e., nursing home) or limited life expectancy as determined by chart review including advanced stage cancer, severe frailty, or other major comorbidity
* Further exclusion criteria include unwillingness to be followed for the duration of the study, participation in another clinical trial or research study, difficulty with communication in English without an interpreter over the telephone, substance abuse, dementia, disability or mental illness that would prohibit ability to provide informed consent or perform home BP monitoring. Additionally, patients are ineligible if they report a major health event requiring hospitalization since the last documented UMMC clinic visit.

Contacts and Locations

Study Contact

LaQuita Cooper, PhD

CONTACT

6019841627

lcooper1@umc.edu

Richards Summers, MD

CONTACT

6018152681

rsummers@umc.edu

Study Locations (Sites)

University of Mississippi Medical Center Cancer Institute

Jackson, Mississippi, 39216

United States

Collaborators and Investigators

Sponsor: University of Mississippi Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01

Study Completion Date2023-05-31

Study Record Updates

Study Start Date2023-02-01

Study Completion Date2023-05-31

Terms related to this study

Additional Relevant MeSH Terms

Hypertension
Breast Cancer