Comorbidities And Reducing inEquitieS

NCT ID: NCT04836221

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2023-06-10

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.

Conditions

Cancer, Breast; Diabetes Mellitus; Hypertension; Cancer Prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Will receive mHealth support for comorbidity and support from a Community Health Worker by phone

Group Type: EXPERIMENTAL

Support

Intervention Type: BEHAVIORAL

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).

Interventions

Support

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Hannah Arem

Scientific Director, Implementation Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hannah Arem, PhD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

00003543

Identifier Type: -

Identifier Source: org_study_id