Cancer, BreastCARESNCT04836221
Comorbidities And Reducing inEquitieS
A study testing Support in people with Cancer, Breast and Diabetes Mellitus, run by Medstar Health Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast, Diabetes Mellitus, Hypertension
- What is being tested?
- Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling to participate in a 6-month study
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
- Conditions
- Cancer, Breast, Diabetes Mellitus, Hypertension, Cancer Prostate
- Being tested
- Support
- Keywords
- Prostate Cancer, Breast Cancer, Diabetes Mellitus, Hypertension, Community Health Workers, mHealth
- Medical subject headings
- Breast Neoplasms, Diabetes Mellitus, Hypertension, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupportBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Will receive mHealth support for comorbidity and support from a Community Health Worker by phone Receives: Behavioral: Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study protocol
Accrual of >50 patients into the study
Measured: 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
Measured: 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
Measured: 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 outcomes (1)
Provider perspectives on acceptability of active management of comorbidities
>80% reporting agree to completely agree on the scale: Acceptability of Intervention Measure (FIM) measure.
Measured: Beginning and end of study (approximately 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start5 May 2021
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, American Cancer Society, Inc.
- Responsible party
- Principal investigator, Hannah Arem, Medstar Health Research Institute
- Investigators
- Hannah Arem, PhD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836221
- Sponsor's protocol ID
- 00003543
- Acronym
- CARES
- Status last verified
- Jun 2023
- First submitted
- 24 Mar 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schubel L, Mete M, Fong A, Boxley C, Barac A, Gallagher C, Magee MF, Arem H. Understanding Perceptions of Care Coordination and Chronic Illness Management among Black Breast and Prostate Cancer Survivors and Providers: Findings from a Quality Improvement Study. J Ambul Care Manage. 2024 Oct-Dec 01;47(4):228-238. doi: 10.1097/JAC.0000000000000505. Epub 2024 Aug 23.
PubMed 39028275
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Interventions to Manage Co-morbidities Among Black Breast and Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04836221
- Acronym / sponsor ID
- CARES / 00003543
- Conditions
- Cancer, Breast, Diabetes Mellitus, Hypertension, Cancer Prostate
- Keywords
- Prostate Cancer, Breast Cancer, Diabetes Mellitus, Hypertension, Community Health Workers, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer, American Cancer Society, Inc.
- Study start
- 5 May 2021 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SupportWill receive mHealth support for comorbidity and support from a Community Health Worker by phone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling to participate in a 6-month study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupportCommunity 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). | Behavioural | Intervention |
Primary outcome
Feasibility of study protocol
Time frame: Study recruitment period will be approximately 12 months
Accrual of >50 patients into the study
Feasibility of an active management strategy for comorbidities
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)
>80% recording blood pressure and/or blood glucose 3+ times per week
Feasibility of an active management strategy for comorbidities
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)
>80% completion of weekly phone calls with community health workers
1 secondary outcome
Provider perspectives on acceptability of active management of comorbidities
Time frame: Beginning and end of study (approximately 18 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 39028275Schubel L, Mete M, Fong A, Boxley C, Barac A, Gallagher C, Magee MF, Arem H. Understanding Perceptions of Care Coordination and Chronic Illness Management among Black Breast and Prostate Cancer Survivors and Providers: Findings from a Quality Improvement Study. J Ambul Care Manage. 2024 Oct-Dec 01;47(4):228-238. doi: 10.1097/JAC.0000000000000505. Epub 2024 Aug 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Arem, PhD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support in people with Cancer, Breast and Diabetes Mellitus, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study protocol (time frame: Study recruitment period will be approximately 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023; AzTrials last refreshed its copy on 26 Oct 2026.