Comorbidities And Reducing inEquitieS (CARES)
Primary Purpose
Cancer, Breast, Diabetes Mellitus, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Support
Sponsored by
About this trial
This is an interventional health services research trial for Cancer, Breast focused on measuring Prostate Cancer, Breast Cancer, Diabetes Mellitus, Hypertension, Community Health Workers, mHealth
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
Sites / Locations
- MedStar Washington Hospital Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Will receive mHealth support for comorbidity and support from a Community Health Worker by phone
Outcomes
Primary Outcome Measures
Feasibility of study protocol
Accrual of >50 patients into the study
Feasibility of an active management strategy for comorbidities
>80% recording blood pressure and/or blood glucose 3+ times per week
Feasibility of an active management strategy for comorbidities
>80% completion of weekly phone calls with community health workers
Secondary Outcome Measures
Provider perspectives on acceptability of active management of comorbidities
>80% reporting agree to completely agree on the scale: Acceptability of Intervention Measure (FIM) measure.
Full Information
NCT ID
NCT04836221
First Posted
March 24, 2021
Last Updated
June 14, 2023
Sponsor
Medstar Health Research Institute
Collaborators
Pfizer, American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04836221
Brief Title
Comorbidities And Reducing inEquitieS
Acronym
CARES
Official Title
Multi-level Interventions to Manage Co-morbidities Among Black Breast and Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
June 10, 2023 (Actual)
Study Completion Date
June 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Pfizer, American Cancer Society, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Diabetes Mellitus, Hypertension, Cancer Prostate
Keywords
Prostate Cancer, Breast Cancer, Diabetes Mellitus, Hypertension, Community Health Workers, mHealth
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Will receive mHealth support for comorbidity and support from a Community Health Worker by phone
Intervention Type
Behavioral
Intervention Name(s)
Support
Intervention Description
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).
Primary Outcome Measure Information:
Title
Feasibility of study protocol
Description
Accrual of >50 patients into the study
Time Frame
Study recruitment period will be approximately 12 months
Title
Feasibility of an active management strategy for comorbidities
Description
>80% recording blood pressure and/or blood glucose 3+ times per week
Time Frame
Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months)
Title
Feasibility of an active management strategy for comorbidities
Description
>80% completion of weekly phone calls with community health workers
Time Frame
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 Measure Information:
Title
Provider perspectives on acceptability of active management of comorbidities
Description
>80% reporting agree to completely agree on the scale: Acceptability of Intervention Measure (FIM) measure.
Time Frame
Beginning and end of study (approximately 18 months)
Other Pre-specified Outcome Measures:
Title
Preliminary changes in self-efficacy
Description
PROMIS Self-Efficacy for Managing Chronic Conditions
Time Frame
To be assess at baseline and end of study; approximately 6-7 months per participant
Title
Preliminary changes in social support
Description
PROMIS Social Support
Time Frame
To be assess at baseline and end of study; approximately 6-7 months per participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Arem, PhD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
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Comorbidities And Reducing inEquitieS
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