Clinical trial NCT04836221: Comorbidities And Reducing inEquitieS
Official title: Multi-level Interventions to Manage Co-morbidities Among Black Breast and Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Diabetes Mellitus
Hypertension
Cancer Prostate
Keywords: Prostate Cancer
Breast Cancer
Diabetes Mellitus
Hypertension
Community Health Workers
mHealth
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
name: American Cancer Society, Inc.
First posted: 2021-04-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Feasibility of study protocol
timeFrame: Study recruitment period will be approximately 12 months
measure: Feasibility of an active management strategy for comorbidities
timeFrame: Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months)
measure: Feasibility of an active management strategy for comorbidities
timeFrame: 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:
measure: Provider perspectives on acceptability of active management of comorbidities
timeFrame: Beginning and end of study (approximately 18 months)
Other outcomes:
measure: Preliminary changes in self-efficacy
timeFrame: To be assess at baseline and end of study; approximately 6-7 months per participant
measure: Preliminary changes in social support
timeFrame: To be assess at baseline and end of study; approximately 6-7 months per participant
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Hannah Arem, PhD
role: PRINCIPAL_INVESTIGATOR
References: