Comorbidities And Reducing inEquitieS

NCT04836221 | Completed

• 1 other identifier: 00003543
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Breast; Diabetes Mellitus; Hypertension; Cancer Prostate

Keywords

Prostate Cancer; Breast Cancer; Diabetes Mellitus; Hypertension; Community Health Workers; mHealth

Outcome Measures

Primary Outcomes (3)

• Feasibility of study protocol

  Accrual of \>50 patients into the study

  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

  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

  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

  Beginning and end of study (approximately 18 months)

Other Outcomes (2)

• Preliminary changes in self-efficacy

  To be assess at baseline and end of study; approximately 6-7 months per participant

• Preliminary changes in social support

  To be assess at baseline and end of study; approximately 6-7 months per participant

Study Arms (1)

Intervention

EXPERIMENTAL

Will receive mHealth support for comorbidity and support from a Community Health Worker by phone

Behavioral: Support

Interventions

Support BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Unwilling to participate in a 6-month study

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Pfizer: collaborator
• American Cancer Society, Inc.: collaborator

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Diabetes Mellitus; Hypertension; Prostatic Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hannah Arem, PhD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, Implementation Science

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 8, 2021
• Study Start: May 5, 2021
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (1)