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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04836221
Other study ID # 00003543
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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