Comorbidities And Reducing inEquitieS

Hypertension Clinical Trial

— CARES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836221
• Other study ID #: 00003543
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: June 10, 2023

Study information

• Verified date: June 2023
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 10, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer Prostate
• Cancer, Breast
• Diabetes Mellitus
• Hypertension

Intervention

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).

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Medstar Health Research Institute	American Cancer Society, Inc., Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Preliminary changes in social support	PROMIS Social Support	To be assess at baseline and end of study; approximately 6-7 months per participant
Primary	Feasibility of study protocol	Accrual of >50 patients into the study	Study recruitment period will be approximately 12 months
Primary	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)
Primary	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	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)