Cancer, Breast, Diabetes Mellitus, Hypertension, Cancer Prostate
Conditions
Keywords
Prostate Cancer, Breast Cancer, Diabetes Mellitus, Hypertension, Community Health Workers, mHealth
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.
Interventions
BEHAVIORALSupport
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).
Sponsors
Pfizer
American Cancer Society, Inc.
Medstar Health Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed