CARES: Comorbidities And Reducing inEquitieS

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04836221

Collaborator

Pfizer (Industry), American Cancer Society, Inc. (Other)

100

Enrollment

Location

Arm

18.9

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast Diabetes Mellitus Hypertension Cancer Prostate	Behavioral: Support	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 5, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Feasibility of study protocol [Study recruitment period will be approximately 12 months]
Accrual of >50 patients into the study
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% recording blood pressure and/or blood glucose 3+ times per week
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

Secondary Outcome Measures

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.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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