Comorbidities And Reducing inEquitieS

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Hypertension; Cancer, Breast; Cancer Prostate
• Interventions: Behavioral: Support

• Registration Number: NCT04836221
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Study Start: 2021-05-05
• Status Verified: 2023-06
• Primary Completion: 2023-06-10
• Study Completion: 2023-06-10
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Support	Will receive mHealth support for comorbidity and support from a Community Health Worker by phone

Primary Outcome Measures

Name	Time	Method
Feasibility of an active management strategy for comorbidities	Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months)	\>80% completion of weekly phone calls with community health workers
Feasibility of study protocol	Study recruitment period will be approximately 12 months	Accrual of \>50 patients into the study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States