Comorbidities And Reducing inEquitieS

Study Overview
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Brief Summary
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Black cancer patients tend to have worse outcomes than White cancer patients. Some of this disparity may be due to comorbidities. The purpose of this study is to improve management of co-morbidities among cancer patients in order to improve cancer outcomes and improve health equity. Comorbidities such as diabetes and hypertension can complicate cancer treatment or can make it difficult to reach optimal health after treatment. This study will offer additional support and tools to manage cancer patient's health needs. First, the study will use a mobile health application, managed by a company called Welldoc, to monitor patient progress in real time and to provide ongoing guidance. Second, the study will connect patients with a Community Health Worker who will speak with them weekly to discuss self-care information, including medical scheduling or appointment needs, and assist with daily self-monitoring of blood pressure and/or blood glucose monitoring. Lastly, an oncology nurse will monitor reported health and triage any medical needs and whether additional medical care is needed.

Official Title
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Multi-level Interventions to Manage Co-morbidities Among Black Breast and Prostate Cancer Patients

Conditions
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Cancer, Breast, Diabetes Mellitus, Hypertension, Cancer Prostate

Intervention / Treatment
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* Behavioral: Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Black women with a diagnosis of stage 0-IV breast cancer and within a month of treatment initiation or with 6+ months of treatment left OR Black men with a history of prostate cancer who are on long-term androgen deprivation therapy; Blood pressure >=120/80 OR diagnosis of diabetes Individuals who develop these conditions during treatment such as those scheduled to initiate steroid-containing chemotherapy or targeted PI3K inhibitor therapies Access to a smartphone and/or internet for the duration of the study. Can understand and communicate in English Exclusion Criteria: - Unwilling to participate in a 6-month study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Will receive mHealth support for comorbidity and support from a Community Health Worker by phone | Behavioral: Support<br>* Community Health Workers will conduct weekly phone calls to monitor blood pressure or blood glucose, to check in on patient need for social, practical or emotional supports, and to encourage healthy lifestyle modification. Participants will also have access to a mobile app to support chronic disease management (Either diabetes or hypertension).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of study protocol | Accrual of >50 patients into the study | Study recruitment period will be approximately 12 months | 
| Feasibility of an active management strategy for comorbidities | >80% recording blood pressure and/or blood glucose 3+ times per week | Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months) | 
| Feasibility of an active management strategy for comorbidities | >80% completion of weekly phone calls with community health workers | Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider perspectives on acceptability of active management of comorbidities | >80% reporting agree to completely agree on the scale: Acceptability of Intervention Measure (FIM) measure. | Beginning and end of study (approximately 18 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Breast Cancer, Diabetes Mellitus, Hypertension, Community Health Workers, mHealth