Comorbidities And Reducing inEquitieS (CARES)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus; Cancer, Breast; Cancer Prostate
• Intervention / Treatment: Behavioral: Support

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Will receive mHealth support for comorbidity and support from a Community Health Worker by phone	Behavioral: 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).

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary changes in self-efficacy	PROMIS Self-Efficacy for Managing Chronic Conditions	To be assess at baseline and end of study; approximately 6-7 months per participant
Preliminary changes in social support	PROMIS Social Support	To be assess at baseline and end of study; approximately 6-7 months per participant

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: Pfizer; American Cancer Society, Inc.
• Investigators: Principal Investigator: Hannah Arem, PhD, Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): June 10, 2023
• Study Completion (Actual): June 10, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Hypertension; Diabetes Mellitus; Prostate Cancer; mHealth; Community Health Workers
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Breast Diseases; Hypertension; Diabetes Mellitus; Breast Neoplasms
• Other Study ID Numbers: 00003543

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No