Telemonitoring Hypertension and Breast Cancer

NCT05574686 | Unknown DMC

• 1 other identifier: UMMCHTNBC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Hypertension; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Control

  The study will provide new and important insights into remote hypertension management using telehealth monitoring from a remote blood pressure cuff. This represents a potential paradigm shift in the ability to move effectively manage hyperextension and other chronic disease on a large scale. The study aims to reduce blood pressure through a comprehensive remote hypertension management program. Participants stand to gain significant benefit from hypertension control. this program is intended to control hypertension without any additionally scheduled clinic visits, and therefore study patients stand to realize the benefit of time and opportunity costs not spent traveling and attending clinic visits.

  6-months

Secondary Outcomes (1)

• Decrease Food Insecurity

  6 months

Study Arms (1)

Telehealth Hypertension and Food Insecurity Intervention

EXPERIMENTAL

Telehealth Hypertension and Food Insecurity Intervention Established clinical telehealth services will be provided to monitor and give behavioral and educational management advice to women with breast cancer to better control their hypertension. Resources for food insecurity will be provided to participants.

Behavioral: Telehealth Blood Pressure Monitoring and Food Insecurity

Interventions

Telehealth Blood Pressure Monitoring and Food Insecurity BEHAVIORAL

Telehealth Blood Pressure Monitoring and Food Insecurity

Telehealth Hypertension and Food Insecurity Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females sex assigned at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• Cheryl Clark, MD, ScD: collaborator
• Saurabh Chandra, MD: collaborator
• Richard Summers, MD: collaborator

Study Sites (1)

University of Mississippi Medical Center Cancer Institute

Jackson, Mississippi, 39216, United States

RECRUITING

Related Publications (3)

• Mendy VL, Rowell-Cunsolo T, Bellerose M, Vargas R, Zhang L, Enkhmaa B. Temporal Trends in Hypertension Death Rate in Mississippi, 2000-2018. Am J Hypertens. 2021 Sep 22;34(9):956-962. doi: 10.1093/ajh/hpab068.

  PMID: 33954415 BACKGROUND

• Berkowitz SA, Basu S, Gundersen C, Seligman HK. State-Level and County-Level Estimates of Health Care Costs Associated with Food Insecurity. Prev Chronic Dis. 2019 Jul 11;16:E90. doi: 10.5888/pcd16.180549.

  PMID: 31298210 BACKGROUND

• Williams MS, Beech BM, Griffith DM, Jr Thorpe RJ. The Association between Hypertension and Race/Ethnicity among Breast Cancer Survivors. J Racial Ethn Health Disparities. 2020 Dec;7(6):1172-1177. doi: 10.1007/s40615-020-00741-7. Epub 2020 Mar 17.

  PMID: 32185742 BACKGROUND

MeSH Terms

Conditions

Hypertension; Breast Neoplasms

Interventions

Food Insecurity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Food Supply; Food Industry; Industry; Technology, Industry, and Agriculture

Central Study Contacts

LaQuita Cooper, PhD

CONTACT

6019841627; lcooper1@umc.edu

Richards Summers, MD

CONTACT

6018152681; rsummers@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Manager

Model Details: Using the telemonitoring kit of iPad to access daily health sessions and remote blood pressure cuff to monitor blood pressure measurements. Patients will then obtain a BP measurement using the appropriate technique described above. Patients are asked to obtain two consecutive BP measurements during each session and register at least 6 sessions per week. Every 2 weeks, BP measurements will be assessed.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 10, 2022
• Study Start: February 1, 2023
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)